今日の臨床サポート

低出生体重児(小児科)

著者: 高橋尚人 東京大学 小児・新生児集中治療部

監修: 五十嵐隆 国立成育医療研究センター

著者校正/監修レビュー済:2022/03/16
参考ガイドライン:
 
  1. 日本周産期・新生児医学会:日本版救急蘇生ガイドライン2020に基づく新生児蘇生法テキスト第4版
  1. 日本小児呼吸器学会/日本新生児成育医学会:小児RSウイルス呼吸器感染症診療ガイドライン2021
  1. 日本新生児成育医学会 医療の標準化委員会内 鉄剤補充ガイドライン作成小委員会:新生児に対する鉄剤投与のガイドライン 2017
患者向け説明資料

概要・推奨   

  1. 早産児においても、出生時の蘇生に100%酸素を用いるべきでない(推奨度1)
  1. 早産児では低体温を予防するのにプラスチックバッグを用いるなど特別の処置をすべきである(推奨度1)
  1. 低出生体重児の治療の際には、酸素を制限して使用することが勧められる(推奨度2)
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
高橋尚人 : 特に申告事項無し[2022年]
監修:五十嵐隆 : 特に申告事項無し[2022年]

改訂のポイント:
  1. 定期レビューを行い、もらい母乳については削除を行った。イブプロフェンは保険適用薬として薬価収載されたため推奨項目からは削除した。その他、用語の更新を行った。
  1. 新生児蘇生法テキストの更新を行った。
  1. 小児RSウイルス呼吸器感染症診療ガイドラインに基づき修正を行った。
  1. 新生児に対する鉄剤投与のガイドライン 2017の文献アップデートを行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 低出生体重児とは出生体重2,500g未満の新生児と定義される。さらに、1,500g未満を極低出生体重児、1,000g未満を超低出生体重児という。
  1. 低出生体重児は予定より早く生まれたことにより体重が小さい早産児と胎児発育不全によるlight-for dates(small-for-dates, small-for-gestational ageもほぼ同じ概念)の2つが含まれる。
  1. 低出生体重児は体重のみで簡単に評価・診断できることから、世界的にひとつの疾患単位として用いられている。
  1. 日本での頻度は、全出生の約9.4%で、2019年に8.1万人だった。
  1. 早産児では未熟性による病態・疾患がみられる。
  1. 胎児発育不全児では、先天異常による場合と胎盤機能不全による場合に大きく二分され、それぞれの病態がある。
問診・診察のポイント  
  1. 診断は体重測定のみで行われるので容易である。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

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文献 

Ola Didrik Saugstad, Siddarth Ramji, Máximo Vento
Resuscitation of depressed newborn infants with ambient air or pure oxygen: a meta-analysis.
Biol Neonate. 2005;87(1):27-34. doi: 10.1159/000080950. Epub 2004 Sep 20.
Abstract/Text BACKGROUND: It is discussed whether depressed newborn infants should be resuscitated with room air or 100% O2.
OBJECTIVE: To perform a systematic review and meta-analysis including studies that report resuscitation of depressed newly born infants with 21 or 100% O2.
METHODS: Inclusion criterion was randomized or pseudo-randomized, blinded or not, studies of depressed newborn infants resuscitated with either 21 or 100% O2. The literature was searched in Medline/Pubmed/EMBASE and The Cochrane library databases. All identified studies were included.
RESULTS: Five studies fulfilled the inclusion criterion in which 881 infants were resuscitated with 21% O2 and 856 with 100% O2. Neonatal mortality was 8.0 vs. 13.0% in the 21 and 100% O2 groups respectively, OR 0.57, 95% CI 0.42-0.78. In term infants neonatal mortality was 5.9% in the 21% O2 group and 9.8% in the 100% O2 group, OR 0.59, 95% CI 0.40-0.87. The figures for the premature infants were very similar. In infants with 1-min Apgar score <4, OR for neonatal mortality was 0.81 (95% CI 0.54-1.21). Apgar score at 5 min and heart rate at 90 s were significantly higher, and time to first breath significantly earlier in infants given 21% O2 compared with 100% O2.
CONCLUSIONS: A systematic review and meta-analysis demonstrated that neonatal mortality is significantly reduced when depressed newly born infants are resuscitated with ambient air instead of pure oxygen. For infants with low 1-min Apgar score (<4), no significant difference in neonatal mortality was found. Recovery was faster in infants resuscitated with 21% O2 than 100% O2.

PMID 15452400
Abstract/Text OBJECTIVE: Birth asphyxia represents a serious problem worldwide, resulting in approximately 1 million deaths and an equal number of serious sequelae annually. It is therefore important to develop new and better ways to treat asphyxia. Resuscitation after birth asphyxia traditionally has been carried out with 100% oxygen, and most guidelines and textbooks recommend this; however, the scientific background for this has never been established. On the contrary, theoretic considerations indicate that resuscitation with high oxygen concentrations could have detrimental effects. We have performed a series of animal studies as well as one pilot study indicating that resuscitation can be performed with room air just as efficiently as with 100% oxygen. To test this more thoroughly, we organized a multicenter study and hypothesized that room air is superior to 100% oxygen when asphyxiated newborn infants are resuscitated.
METHODOLOGY: In a prospective, international, controlled multicenter study including 11 centers from six countries, asphyxiated newborn infants with birth weight >999 g were allocated to resuscitation with either room air or 100% oxygen. The study was not blinded, and the patients were allocated to one of the two treatment groups according to date of birth. Those born on even dates were resuscitated with room air and those born on odd dates with 100% oxygen. Informed consent was not obtained until after the initial resuscitation, an arrangement in agreement with the new proposal of the US Food and Drug Administration's rules governing investigational drugs and medical devices to permit clinical research on emergency care without the consent of subjects. The protocol was approved by the ethical committees at each participating center. Entry criterion was apnea or gasping with heart rate <80 beats per minute at birth necessitating resuscitation. Exclusion criteria were birth weight <1000 g, lethal anomalies, hydrops, cyanotic congenital heart defects, and stillbirths. Primary outcome measures were death within 1 week and/or presence of hypoxic-ischemic encephalopathy, grade II or III, according to a modification of Sarnat and Sarnat. Secondary outcome measures were Apgar score at 5 minutes, heart rate at 90 seconds, time to first breath, time to first cry, duration of resuscitation, arterial blood gases and acid base status at 10 and 30 minutes of age, and abnormal neurologic examination at 4 weeks. The existing routines for resuscitation in each participating unit were followed, and the ventilation techniques described by the American Heart Association were used as guidelines aiming at a frequency of manual ventilation of 40 to 60 breaths per minute.
RESULTS: Forms for 703 enrolled infants from 11 centers were received by the steering committee. All 94 patients from one of the centers were excluded because of violation of the inclusion criteria in 86 of these. Therefore, the final number of infants enrolled in the study was 609 (from 10 centers), with 288 in the room air group and 321 in the oxygen group. Median (5 to 95 percentile) gestational ages were 38 (32.0 to 42.0) and 38 (31.1 to 41.5) weeks (NS), and birth weights were 2600 (1320 to 4078) g and 2560 (1303 to 3900) g (NS) in the room air and oxygen groups, respectively. There were 46% girls in the room air and 41% in the oxygen group (NS). Mortality in the first 7 days of life was 12.2% and 15.0% in the room air and oxygen groups, respectively; adjusted odds ratio (OR) = 0.82 with 95% confidence intervals (CI) = 0.50-1.35. Neonatal mortality was 13.9% and 19.0%; adjusted OR = 0. 72 with 95% CI = 0.45-1.15. Death within 7 days of life and/or moderate or severe hypoxic-ischemic encephalopathy (primary outcome measure) was seen in 21.2% in the room air group and in 23.7% in the oxygen group; OR = 0.94 with 95% CI = 0.63-1.40. (ABSTRACT TRUNCATED)

PMID 9651453
Emma M McCall, Fiona Alderdice, Henry L Halliday, John G Jenkins, Sunita Vohra
Interventions to prevent hypothermia at birth in preterm and/or low birthweight infants.
Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004210. doi: 10.1002/14651858.CD004210.pub4. Epub 2010 Mar 17.
Abstract/Text BACKGROUND: Keeping vulnerable preterm infants warm is problematic even when recommended routine thermal care guidelines are followed in the delivery suite.
OBJECTIVES: To assess efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birthweight infants applied within 10 minutes after birth in the delivery suite compared with routine thermal care.
SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). The review was updated in October 2009.
SELECTION CRITERIA: Trials using randomised or quasi-randomised allocations to test a specific intervention designed to prevent hypothermia, (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery suite to infants of < 37 weeks' gestational age or birthweight DATA COLLECTION AND ANALYSIS: We used the methods of the CNRG for data collection and analysis.
MAIN RESULTS: 1) Barriers to heat loss [5 studies; plastic wrap or bag (3), plastic cap (1), stockinet cap (1)]:Plastic wraps or bags were effective in reducing heat losses in infants < 28 weeks' gestation (4 studies, n = 223; WMD 0.68 degrees C; 95% CI 0.45, 0.91), but not in infants between 28 to 31 week's gestation. Plastic caps were effective in reducing heat losses in infants < 29 weeks' gestation (1 study, n = 64; MD 0.80 degrees C; 95% CI 0.41, 1.19). There was insufficient evidence to suggest that either plastic wraps or plastic caps reduce the risk of death within hospital stay. There was no evidence of significant differences in other clinical outcomes for either the plastic wrap/bag or the plastic cap comparisons. Stockinet caps were not effective in reducing heat losses.2) External heat sources [2 studies; skin-to-skin (1), transwarmer mattress (1)]:Skin-to-skin care (SSC) was shown to be effective in reducing the risk of hypothermia when compared to conventional incubator care for infants (1 study, n = 31; RR 0.09; 95% CI 0.01, 0.64). The transwarmer mattress reduced the incidence of hypothermia on admission to NICU in VLBW infants (1 study, n = 24; RR 0.30; 95% CI 0.11, 0.83).
AUTHORS' CONCLUSIONS: Plastic wraps or bags, plastic caps, SSC and transwarmer mattresses all keep preterm infants warmer leading to higher temperatures on admission to neonatal units and less hypothermia. However, the small numbers of infants and studies and the absence of long-term follow-up mean that firm recommendations for clinical practice cannot be given.

PMID 20238329
Sunita Vohra, Robin S Roberts, Bo Zhang, Marianne Janes, Barbara Schmidt
Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants.
J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
Abstract/Text OBJECTIVES: To determine if polyethylene occlusive skin wrapping of very preterm infants prevents heat loss after delivery better than conventional drying and to evaluate if any benefit is sustained after wrap removal.
STUDY DESIGN: This was a randomized controlled trial of infants <28 weeks' gestation. The experimental group was wrapped from the neck down. Only the head was dried. Control infants were dried completely. Rectal temperatures were compared on admission to the neonatal intensive care unit immediately after wrap removal and 1 hour later.
RESULTS: Of 55 infants randomly assigned (28 wrap, 27 control), 2 died in the delivery room and 53 completed the study. Wrapped infants had a higher mean rectal admission temperature, 36.5 degrees C (SD, 0.8 degrees C), compared with 35.6 degrees C (SD, 1.3 degrees C) in control infants ( P = .002). One hour later, mean rectal temperatures were similar in both groups (36.6 degrees C, SD, 0.7 degrees C vs 36.4 degrees C, SD, 0.9 degrees C, P = .4). Size at birth was an important determinant of heat loss: Mean rectal admission temperature increased by 0.21 degrees C (95% CI, 0.04 to 0.4) with each 100-g increase in birth weight.
CONCLUSIONS: Polyethylene occlusive skin wrapping prevents rather than delays heat loss at delivery in very preterm infants.

PMID 15580195
Lisa M Askie, David J Henderson-Smart, Henry Ko
Restricted versus liberal oxygen exposure for preventing morbidity and mortality in preterm or low birth weight infants.
Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001077. doi: 10.1002/14651858.CD001077.pub2. Epub 2009 Jan 21.
Abstract/Text BACKGROUND: While the use of supplemental oxygen has a long history in neonatal care, resulting in both significant health care benefits and harms, uncertainty remains as to the most appropriate range to target blood oxygen levels in preterm and low birth weight infants. Potential benefits of higher oxygen targeting may include more stable sleep patterns and improved long-term growth and development. However, there may be significant deleterious pulmonary effects and health service use implications resulting from such a policy.
OBJECTIVES: To determine whether targeting ambient oxygen concentration to achieve a lower vs. higher blood oxygen range, or administering restricted vs. liberal supplemental oxygen, effects mortality, retinopathy of prematurity, lung function, growth or development in preterm or low birth weight infants.
SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. An additional literature search was conducted of the MEDLINE and CINAHL databases in order to locate any trials in addition to those provided by the Cochrane Controlled Trials Register (CENTRAL/CCTR). Search updated to week two July 2008.
SELECTION CRITERIA: All trials in preterm or low birth weight infants utilising random or quasi-random patient allocation in which ambient oxygen concentrations were targeted to achieve a lower vs. higher blood oxygen range, or restricted vs. liberal oxygen was administered were eligible for inclusion.
DATA COLLECTION AND ANALYSIS: The methodological quality of the eligible trials was assessed independently by each review author for the degree of selection, performance, attrition and detection bias. Data were extracted and reviewed independently by the each author. Data analysis was conducted according to the standards of the Cochrane Neonatal Review Group.
MAIN RESULTS: In the meta-analysis of the five trials included in this review, the restriction of oxygen significantly reduced the incidence and severity of retinopathy of prematurity without unduly increasing death rates The one prospective, multicenter, double-blind, randomized trial investigating lower vs. higher blood oxygen levels from 32 weeks postmenstrual age showed no significant differences in the rates of ROP, mortality or growth and development between the two groups. However, this study did show increased rates of chronic lung disease and home oxygen use.
AUTHORS' CONCLUSIONS: The results of this systematic review confirm that (the now historical) policy of unrestricted, unmonitored oxygen therapy has potential harms without clear benefits. However, the question of what is the optimal target range for maintaining blood oxygen levels in preterm/LBW infants was not answered by the data available for inclusion in this review.

PMID 19160188
Lisa Maree Askie, David John Henderson-Smart, Les Irwig, Judy Margaret Simpson
Oxygen-saturation targets and outcomes in extremely preterm infants.
N Engl J Med. 2003 Sep 4;349(10):959-67. doi: 10.1056/NEJMoa023080.
Abstract/Text BACKGROUND: Physiological studies have shown that chronic hypoxemia may occur in preterm infants who require supplemental oxygen for extended periods and that this hypoxemia may contribute to poor growth and development. Anecdotal reports and uncontrolled observational studies have suggested that a higher oxygen-saturation range may be beneficial in terms of growth and development.
METHODS: We conducted a multicenter, double-blind, randomized, controlled trial involving 358 infants born at less than 30 weeks of gestation who remained dependent on supplemental oxygen at 32 weeks of postmenstrual age. They were randomly assigned to a target functional oxygen-saturation range of either 91 to 94 percent (standard-saturation group) or 95 to 98 percent (high-saturation group); this target was maintained for the duration of supplemental-oxygen therapy. The primary outcomes were growth and neurodevelopmental measures at a corrected age of 12 months.
RESULTS: There were no significant differences between the groups in weight, length, or head circumference at a corrected age of 12 months. The frequency of major developmental abnormalities also did not differ significantly between the standard-saturation group and the high-saturation group (24 percent and 23 percent, respectively, P=0.85). There were six deaths due to pulmonary causes in the high-saturation group and one such death in the standard-saturation group (P=0.12). The high-saturation group received oxygen for a longer period after randomization (median, 40 days vs. 18 days; P<0.001) and had a significantly higher rate of dependence on supplemental oxygen at 36 weeks of postmenstrual age and a significantly higher frequency of home-based oxygen therapy.
CONCLUSIONS: Targeting a higher oxygen-saturation range in extremely preterm infants who were dependent on supplemental oxygen conferred no significant benefit with respect to growth and development and resulted in an increased burden on health services.

Copyright 2003 Massachusetts Medical Society
PMID 12954744
Giovanni Vento, Piero G Matassa, Franco Ameglio, Ettore Capoluongo, Enrico Zecca, Luca Tortorolo, Mara Martelli, Costantino Romagnoli
HFOV in premature neonates: effects on pulmonary mechanics and epithelial lining fluid cytokines. A randomized controlled trial.
Intensive Care Med. 2005 Mar;31(3):463-70. doi: 10.1007/s00134-005-2556-x. Epub 2005 Feb 17.
Abstract/Text OBJECTIVE: Ventilation strategies for preterm neonates may influence the severity of pulmonary dysfunction and later development of chronic lung disease. The objective of this report is to compare the effects of high-frequency oscillatory ventilation (HFOV) versus synchronized intermittent mandatory ventilation (sIMV) from the points of views of biochemical and functional variables.
DESIGN: Randomized controlled trial.
SETTING: Third level NICU.
PATIENTS AND PARTICIPANTS: Forty preterm neonates with a gestational age of 24-29 weeks were randomly assigned to one of the two above-mentioned ventilation strategies within 30 min from birth.
MEASUREMENTS AND RESULTS: At 1, 3, 5, and 7 days, the babies were monitored by means of ventilator indices, pulmonary function, and eight pro-inflammatory or anti-inflammatory cytokines measured in bronchoalveolar lavage fluid. The neonates assigned to the HFOV procedure benefited from early and sustained improvement in pulmonary mechanics and gas exchange-significantly higher dynamic respiratory compliance values, significantly lower expiratory airway resistance and oxygenation index values-with earlier extubation as compared to the neonates assigned to sIMV treatment, and showed significantly lower transforming growth factor-beta1 concentrations in bronchoalveolar lavage fluid.
CONCLUSIONS: The results of this randomized clinical trial support the hypothesis that early and exclusive use of HFOV, combined with optimum volume strategy, has a beneficial effect during the acute phase of lung injury.

PMID 15717206
Filip Cools, David J Henderson-Smart, Martin Offringa, Lisa M Askie
Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants.
Cochrane Database Syst Rev. 2009 Jul 8;(3):CD000104. doi: 10.1002/14651858.CD000104.pub3. Epub 2009 Jul 8.
Abstract/Text BACKGROUND: Respiratory failure due to lung immaturity is a major cause of mortality in preterm infants. Although the use of intermittent positive pressure ventilation (IPPV) in neonates with respiratory failure saves lives, its use is associated with lung injury and chronic lung disease (CLD). A newer form of ventilation called high frequency oscillatory ventilation (HFOV) has been shown to result in less lung injury in experimental studies.
OBJECTIVES: The objective of this review is to determine the effect of the elective use of high frequency oscillatory ventilation (HFOV) as compared to conventional ventilation (CV) on the incidence of chronic lung disease, mortality and other complications associated with prematurity and assisted ventilation in preterm infants who are mechanically ventilated for respiratory distress syndrome (RDS).
SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching by the Cochrane Collaboration, mainly in the English language. The search was updated in January 2009.
SELECTION CRITERIA: Randomised controlled trials comparing HFOV and CV in preterm or low birth weight infants with pulmonary dysfunction, mainly due to RDS, who required assisted ventilation. Randomisation and commencement of treatment needed to be as soon as possible after the start of CV and usually in the first 12 hours of life.
DATA COLLECTION AND ANALYSIS: The methodological quality of each trial was independently reviewed by the various authors. The standard effect measures are relative risk (RR) and risk difference (RD). From 1/RD the number needed to treat (NNT) to produce one outcome were calculated. For all measures of effect, 95% confidence intervals were used. In subgroup analyses the 99% CIs are also given for summary RRs in the text. Meta-analysis was performed using a fixed effects model. Where heterogeneity was over 50%, the random effects RR is also given.
MAIN RESULTS: Seventeen eligible studies of 3,652 infants were included. Meta-analysis comparing HFOV with CV revealed no evidence of effect on mortality at 28 - 30 days of age or at approximately term equivalent age. These results were consistent across studies and in subgroup analyses. The effect of HFOV on CLD in survivors at term equivalent gestational age was inconsistent across studies and the reduction was of borderline significance overall. The effect was similar in trials with a high lung volume strategy for HFOV targeting at very low FiO(2) and trials with a high lung volume strategy with somewhat higher or unspecified target FiO(2). Subgroups of trials showed a significant reduction in CLD with HFOV when no surfactant was used, when piston oscillators were used for HFOV, when lung protective strategies for CV were not used, when randomisation occurred at two to six hours of age, and when inspiratory:expiratory ratio of 1:2 was used for HFOV. In the meta-analysis of all trials, pulmonary air leaks occurred more frequently in the HFOV group.In some studies, short-term neurological morbidity with HFOV was found, but this effect was not statistically significant overall. The subgroup of two trials not using a high volume strategy with HFOV found increased rates of Grade 3 or 4 intraventricular haemorrhage and of periventricular leukomalacia. An adverse effect of HFOV on long-term neurodevelopment was found in one large trial but not in the five other trials that reported this outcome. The rate of retinopathy of prematurity is reduced overall in the HFOV group.
AUTHORS' CONCLUSIONS: There is no clear evidence that elective HFOV offers important advantages over CV when used as the initial ventilation strategy to treat preterm infants with acute pulmonary dysfunction. There may be a small reduction in the rate of CLD with HFOV use, but the evidence is weakened by the inconsistency of this effect across trials and the overall borderline significance. Future trials on elective HFOV should target those infants who are at most risk of CLD (extremely preterm infants), compare different strategies for generating HFOV and CV, and report important long-term neurodevelopmental outcomes.

PMID 19588317
Wes Onland, Martin Offringa, Anton van Kaam
Late (≥ 7 days) inhalation corticosteroids to reduce bronchopulmonary dysplasia in preterm infants.
Cochrane Database Syst Rev. 2012 Apr 18;4:CD002311. doi: 10.1002/14651858.CD002311.pub3. Epub 2012 Apr 18.
Abstract/Text BACKGROUND: Bronchopulmonary dysplasia (BPD), defined as oxygen dependence at 36 weeks postmenstrual age (PMA), remains an important complication of prematurity. Pulmonary inflammation plays a central role in the pathogenesis of BPD. Attenuating pulmonary inflammation with postnatal systemic corticosteroids reduces the incidence of BPD in preterm infants but may be associated with an increased risk of adverse neurodevelopmental outcomes. Local administration of corticosteroids via inhalation might be an effective and safe alternative.
OBJECTIVES: To determine if administration of inhalation corticosteroids after the first week of life to preterm infants at high risk of developing BPD is effective and safe in reducing the incidence of death and BPD as separate or combined outcomes.
SEARCH METHODS: We identified randomised, controlled trials by searching the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), PubMed (from 1966), EMBASE (from 1974), CINAHL (from 1982), references from retrieved trials and handsearches of journals, all assessed to February 2012.
SELECTION CRITERIA: Randomised controlled trials comparing inhalation corticosteroids, started ≥ 7 days postnatal age (PNA) but before 36 weeks PMA, to placebo in ventilated and non-ventilated infants at risk of BPD were included. Trials investigating systemic corticosteroids versus inhalation corticosteroids were excluded.
DATA COLLECTION AND ANALYSIS: Data on patient characteristics, trial methodology, and inhalation regimens were collected. The primary outcomes were death or BPD, or both, at 28 days PNA or 36 weeks PMA. Secondary outcomes were short-term respiratory outcomes, such as failure to extubate, total days of mechanical ventilation and oxygen use, and the need for systemic corticosteroids. The original trialists were contacted to verify the validity of extracted data and to provide missing data. All data were analysed using RevMan 5.0.24. When possible, meta-analysis was performed using typical risk ratio (TRR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes along with their 95% confidence intervals (CI). Ventilated and non-ventilated participants were analysed separately.
MAIN RESULTS: Eight trials randomising 232 preterm infants were included in this review. Inhalation corticosteroids did not reduce the separate or combined outcomes of death or BPD. Furthermore, inhalation steroids did not impact short-term respiratory outcomes such as failure to extubate and total duration of mechanical ventilation or oxygen dependency. There was a trend to a reduced use of systemic corticosteroids in favour of inhalation corticosteroids (TRR 0.51; 95% CI 0.26 to 1.00). There was a paucity of data on short-term and long-term adverse effects. These results should be interpreted with caution because the total number of randomised patients is relatively small and most trials differed considerably in patient characteristics, inhalation therapy and outcome definitions.
AUTHORS' CONCLUSIONS: Based on the results of the currently available evidence, inhalation corticosteroids initiated at ≥ 7 days of life for preterm infants at high risk of developing BPD cannot be recommended at this point in time. More and larger randomised, placebo-controlled trials are needed to establish the efficacy and safety of inhalation corticosteroids.

PMID 22513906
Marc-André Dugas, Diep Nguyen, Lyne Frenette, Christian Lachance, Odette St-Onge, Annie Fougères, Sylvie Bélanger, Georges Caouette, Eric Proulx, Marie-Claude Racine, Bruno Piedboeuf
Fluticasone inhalation in moderate cases of bronchopulmonary dysplasia.
Pediatrics. 2005 May;115(5):e566-72. doi: 10.1542/peds.2004-0951. Epub 2005 Apr 15.
Abstract/Text OBJECTIVE: This randomized, controlled trial was designed to determine the efficacy of inhaled fluticasone propionate on oxygen therapy weaning in a population of preterm infants who were born at <32 weeks of gestation and experienced moderate bronchopulmonary dysplasia (BPD).
METHODS: Thirty-two infants who were < or =32 weeks of gestation, had moderate BPD that required supplemental oxygen (fraction of inspired oxygen > or =0.25), and were aged between 28 and 60 days were randomized. Fluticasone propionate 125 microg twice daily for 3 weeks and once daily for a fourth week was delivered to infants who weighed between 500 and 1200 g. The dosage was doubled for infants who weighed > or =1200 g.
RESULTS: Compared with placebo, treatment had no effect on either duration of supplemental O2 therapy or ventilatory support as assessed by survival analysis. At 28 days, a trend toward a lower cortisol/creatinine ratio in the treatment group was noted compared with placebo (25.1 +/- 18.9 vs 43 +/- 14.4). In the fluticasone group at 28 days, the systolic arterial pressure (78 +/- 3 vs 68 +/- 3 mm Hg) and diastolic arterial pressure (43 +/- 3.4 mm Hg vs 38 +/- 2.0 mm Hg) were higher compared with baseline fluticasone values. The chest radiograph score was lower than baseline (2.8 +/- 1.4 vs 3.7 +/- 2.2) in the fluticasone group at 28 days. This study has a statistical power of 1.0 to detect a significant difference in the duration of oxygen supplementation of >21 days between the study groups.
CONCLUSION: We conclude that fluticasone propionate reduces neither supplemental O2 use nor the need for ventilatory support in this patient population. However, fluticasone does have a positive radiologic effect in lowering chest radiograph scores. In addition, our data point to a possible association among inhaled fluticasone treatment and higher arterial blood pressure. Thus, the results of this investigation do not support the use of inhaled corticosteroids in the treatment of oxygen-dependent infants who have established moderate BPD.

PMID 15833887
S B Ainsworth, L Clerihew, W McGuire
Percutaneous central venous catheters versus peripheral cannulae for delivery of parenteral nutrition in neonates.
Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004219. doi: 10.1002/14651858.CD004219.pub3. Epub 2007 Jul 18.
Abstract/Text BACKGROUND: Parenteral nutrition for neonates may be delivered via a short peripheral cannula or a central venous catheter. The latter may either be inserted via the umbilicus or percutaneously. Because of the complications associated with umbilical venous catheter use, many neonatal units prefer to use percutaneously inserted catheters following the initial stabilisation period. The method of parenteral nutrition delivery may affect nutrient input and consequently growth and development. Although potentially more difficult to place, percutaneous central venous catheters may be more stable than peripheral cannulae, and need less frequent replacement. These delivery methods may also be associated with different risks of adverse events, including acquired systemic infection and extravasation injury.
OBJECTIVES: To determine the effect of infusion via a percutaneous central venous catheter versus a peripheral cannula on nutrient input, growth and development, and complications including systemic infection, or extravasation injuries in newborn infants who require parenteral nutrition.
SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007), MEDLINE (1966 - February 2007), EMBASE (1980 - February 2007), conference proceedings, and previous reviews.
SELECTION CRITERIA: Randomised controlled trials that compared the effect of delivering parenteral nutrition via a percutaneous central venous catheter versus a peripheral cannulae in neonates.
DATA COLLECTION AND ANALYSIS: Data were extracted the data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by each author, and synthesis of data using relative risk, risk difference and mean difference.
MAIN RESULTS: Four trials eligible for inclusion were found. These trials recruited a total of 368 infants and reported a number of different outcomes. One study showed that the use of a percutaneous central venous catheter was associated with a decreased risk of cumulative nutritional deficit during the trial period: Mean difference in the percentage of the prescribed nutritional intake actually received: -7.1% (95% confidence interval -11.02, -3.2). In another trial, infants in the percutaneous central venous catheter group needed significantly fewer catheters/cannulae per infant during the trial period: Mean difference in the number of catheters/cannulae per infant: -3.2 (95% confidence interval -5.13, -1.27). Meta-analysis of data from all four trials did not find any evidence of an effect on the incidence of systemic infection: Typical relative risk: 0.94 (95% confidence interval 0.70, 1.25); typical risk difference: -0.02 (95% confidence interval -0.12, 0.08).
AUTHORS' CONCLUSIONS: Data from one small study suggest that the use of a percutaneous central venous catheter to deliver parenteral nutrition in newborn infants improves nutrient input. The significance of this in relation to long-term growth and developmental outcomes is unclear. Another study suggested that the use of a percutaneous central venous catheter rather than a peripheral cannula decreases the number of catheters/cannulae needed to deliver the nutrition. No evidence was found to suggest that percutaneous central venous catheter use increased the risk of adverse events, particularly systemic infection.

PMID 17636749
D Wilson, M T Verklan, K A Kennedy
Randomized trial of percutaneous central venous lines versus peripheral intravenous lines.
J Perinatol. 2007 Feb;27(2):92-6. doi: 10.1038/sj.jp.7211650.
Abstract/Text OBJECTIVE: To compare the occurrence of systemic infection or death in preterm infants with elective percutaneous central line (PCVL) placement versus peripheral intravenous catheter (PIV) placement.
STUDY DESIGN: A total of 96 infants < or =1250 g or < or =30 weeks gestation were randomized by 4 days of age to elective placement of a PCVL or continued use of PIV catheters. The primary outcome of systemic infection (defined as a positive blood or cerebrospinal fluid (CSF) culture treated for at least 5 days) or death was monitored until the infants did not require intravenous (iv) support for 7 consecutive days.
RESULTS: Systemic infection or death occurred in 17/46 (39%) infants in the PCVL group and 14/50 (28%) in the PIV group (relative risk (RR)=1.32 with 95% confidence interval (CI) 0.70, 2.53; risk difference (RD)=0.09 with 95% CI -0.10, 0.28). The PCVL group had significantly fewer skin punctures for iv access.
CONCLUSION: There was no significant difference in systemic infection or death (expressed either as a combined outcome or as separate component outcomes) between the groups. The number of skin punctures was significantly reduced in the PCVL group.

PMID 17262041
G Dimitriou, A Greenough, V Kavvadia, B Laubscher, C Alexiou, V Pavlou, S Mantagos
Elective use of nasal continuous positive airways pressure following extubation of preterm infants.
Eur J Pediatr. 2000 Jun;159(6):434-9.
Abstract/Text UNLABELLED: The aim of this study was to determine whether elective use of nasal continuous positive airways pressure (CPAP) following extubation of preterm infants was well tolerated and improved short- and long-term outcomes. A randomized comparison of nasal CPAP to headbox oxygen was undertaken and a meta-analysis performed including similar randomized trials involving premature infants less than 28 days of age. A total of 150 infants (median gestational age 30 weeks, range 24-34 weeks) were randomized in two centres. Fifteen nasal CPAP infants and 25 headbox infants required increased respiratory support post-extubation and 15 nasal CPAP infants and nine headbox infants required reintubation (non significant). Eight infants became intolerant of CPAP and were changed to headbox oxygen within 48 h of extubation; 19 headbox infants developed apnoeas and respiratory acidosis requiring rescue nasal CPAP, 3 ultimately were re-intubated. Seven other trials were identified, giving a total number of 569 infants. Overall, nasal CPAP significantly reduced the need for increased respiratory support (relative risk, 0.57, 95% CI 0.43-0.73), but not for re-intubation (relative risk 0.89, 95% CI 0.68-1.17). Nasal CPAP neither influenced significantly the intraventricular haemorrhage rate reported in four studies (relative risk 1.0, 95% CI 0.55, 1.82) nor that of oxygen dependency at 28 days reported in six studies (relative risk 1.0, 95% CI 0.8, 1.25). In two studies nasal CPAP had to be discontinued in 10% of infants either because of intolerance or hyperoxia.
CONCLUSION: Elective use of nasal continuous positive airways pressure post-extubation is not universally tolerated, but does reduce the need for additional support.

PMID 10867849
P G Davis, D J Henderson-Smart
Nasal continuous positive airways pressure immediately after extubation for preventing morbidity in preterm infants.
Cochrane Database Syst Rev. 2003;(2):CD000143. doi: 10.1002/14651858.CD000143.
Abstract/Text BACKGROUND: Preterm infants being extubated following a period of intermittent positive pressure ventilation via an endotracheal tube are at risk of developing respiratory failure as a result of apnea, respiratory acidosis and hypoxia. Nasal continuous positive airway pressure appears to stabilise the upper airway, improve lung function and reduce apnea and may therefore have a role in facilitating extubation in this population.
OBJECTIVES: In preterm infants having their endotracheal tube removed following a period of intermittent positive pressure ventilation (IPPV), does management with nasal continuous positive airways pressure (NCPAP) lead to an increased proportion remaining free of additional ventilatory support, compared to extubation directly to headbox oxygen?
SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE up to November 2002, Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2002), previous reviews including cross references, abstracts of conferences and symposia proceedings, expert informants and journal handsearching mainly in the English language.
SELECTION CRITERIA: All trials utilising random or quasi-random patient allocation, in which NCPAP (delivered by any method) was compared with headbox oxygen for post-extubation care were included. Methodological quality was assessed independently by the two authors.
DATA COLLECTION AND ANALYSIS: Data were extracted independently by the two authors. Prespecified subgroup analysis to determine the impact of different levels of NCPAP, differences in duration of IPPV and use of aminophylline were also performed using the same package. Data were analysed using relative risk (RR), risk difference (RD) and number needed to treat (NNT).
MAIN RESULTS: Nasal CPAP, when applied to preterm infants being extubated following IPPV, reduces the incidence of adverse clinical events (apnea, respiratory acidosis and increased oxygen requirements) indicating the need for additional ventilatory support [RR 0.62 (0.49, 0.77), RD -0.17 (-0.24,-0.10), NNT 6 (4,10)].
REVIEWER'S CONCLUSIONS:
IMPLICATIONS FOR PRACTICE: nasal CPAP is effective in preventing failure of extubation in preterm infants following a period of endotracheal intubation and IPPV. Implication for research: further definition of the gestational age and weight groups in whom these results apply is required. Optimal levels of NCPAP as well as methods of administration remain to be determined.

PMID 12804388
Iris Morag, Arne Ohlsson
Cycled light in the intensive care unit for preterm and low birth weight infants.
Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006982. doi: 10.1002/14651858.CD006982.pub2. Epub 2011 Jan 19.
Abstract/Text BACKGROUND: The potential benefits and harms of different lighting in neonatal units have not been quantified.
OBJECTIVES: To compare the effectiveness of cycled lighting (CL) (approximately 12 hours of light on and 12 hours of light off) with irregularly dimmed light or near darkness (ND) and with continuous bright light (CBL) on growth in preterm infants at three and six months of age.
SEARCH STRATEGY: Electronic searches of the literature were conducted (in May 2010) of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL and abstracts from Pediatric Academic Societies' annual meetings.
SELECTION CRITERIA: Randomised or quasi-randomised trials of CL versus ND or CBL in preterm and low birth weight infants.
DATA COLLECTION AND ANALYSIS: Data collection and analyses were performed according to the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS: Five studies enrolling 387 infants compared CL to ND. No study reported on weight at three or six months. In one study (n = 40) there was no statistically significant difference in weight at four months between the CL and the ND groups. In another study (n = 62) the ratio of day-night activity prior to discharge favoured the CL group (mean difference 0.18, 95% CI 0.17 to 0.19) indicating 18% more activity during day than night in the CL group compared to the ND group. Two studies (n = 189) reported on retinopathy of prematurity (stage ≥ 3). There was no statistically significant difference between the CL and ND groups (typical RR 0.53, 95% CI 0.25 to 1.11, I(2) = 0%; typical RD -0.09, 95% CI -0.19 to 0.01, I(2) = 0%).Two studies enrolling 82 infants compared CL to CBL. One study (n = 41) reported higher mean weight at three months corrected age in infants cared for in the CL nursery (P < 0.02) and lower mean number of hours spent awake in 24 hours at three months (P < 0.005). In one study (n = 41) days on a ventilator were reduced in the CL group (mean difference -18, 95% CI -31 to -5 days).For many outcomes the trends favoured CL versus ND as well as CL versus CBL.
AUTHORS' CONCLUSIONS: Trials assessing the effect of CL have enrolled 469 infants. Trends for many outcomes favoured cycled light (CL) compared to near darkness (ND) and CL compared to continuous bright light (CBL) The studies may have lacked significance due to a lack of statistical power. Future research should focus on comparing CL to ND.

PMID 21249685
Scott A Rivkees, Linda Mayes, Harris Jacobs, Ian Gross
Rest-activity patterns of premature infants are regulated by cycled lighting.
Pediatrics. 2004 Apr;113(4):833-9.
Abstract/Text OBJECTIVES: Many hospitalized premature infants are exposed to continuous dim lighting rather than to cycled lighting. However, we do not know whether dim lighting or low-intensity cycled lighting is more conducive to the development of rest-activity patterns that are in phase with the solar light-dark cycle. Thus, we examined the effects of nursery lighting conditions on the development of activity patterns in premature infants.
METHODS: Premature infants who were born at <32 weeks' postmenstrual age and were medically stable in neonatal intensive care unit rooms were randomly assigned between 32 and 34 weeks' postmenstrual age to either continuous dim lighting (<25 lux; duration 24 days; control group; n = 29) or cycled lighting (239 +/- 29 lux, 7:00 AM to 7:00 PM; <25 lux, 7:00 PM to 7:00 AM; duration: 25 days; experimental group; n = 33). Activity was continuously monitored from enrollment until approximately 1 month after discharge from the hospital. Weight and head circumference were also assessed up to 6 months after discharge from the hospital.
RESULTS: Over the first 10 days at home, distinct day-night differences in activity were not seen in control subjects (D day-night: N 1.07 +/- 0.02), but experimental group infants were more active during the day than at night (day-night: 1.25 +/- 0.03). It was not until 21 to 30 days after discharge that day-night activity ratios in control infants matched those seen in experimental group infants shortly after discharge, yet even at this age, experimental group infants (day-night: 2.13 +/- 0.19) were considerably more active during the day than at night as compared with control subjects (day-night: 1.43 +/- 0.09).
CONCLUSION: Exposure of premature infants to low-intensity cycled lighting in the hospital nursery induces distinct patterns of rest-activity that are apparent within 1 week after discharge. In comparison, the appearance of distinct patterns of rest and activity are delayed in infants who are exposed to continuous dim lighting in the hospital. These observations show that day-night rhythms in activity patterns can be detected shortly after discharge to home in premature infants and that the circadian clock of developing infants is entrained by cycled lighting.

PMID 15060235
Arne Ohlsson, Janet B Lacy
Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants.
Cochrane Database Syst Rev. 2013 Jul 2;7:CD000361. doi: 10.1002/14651858.CD000361.pub3. Epub 2013 Jul 2.
Abstract/Text BACKGROUND: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight (LBW) infants. Preterm infants are deficient in immunoglobulin G (IgG); therefore, administration of intravenous immunoglobulin (IVIG) may have the potential of preventing or altering the course of nosocomial infections.
OBJECTIVES: To use systematic review/meta-analytical techniques to determine whether IVIG administration (compared with placebo or no intervention) to preterm (< 37 weeks' postmenstrual age (PMA) at birth) or LBW (< 2500 g birth weight) infants or both is effective/safe in preventing nosocomial infection.
SEARCH METHODS: For this update, MEDLINE, EMBASE, CINAHL, The Cochrane Library, Controlled Trials, ClinicalTrials.gov and PAS Abstracts2view were searched in May 2013.
SELECTION CRITERIA: We selected randomised controlled trials (RCTs) in which a group of participants to whom IVIG was given was compared with a control group that received a placebo or no intervention for preterm (< 37 weeks' gestational age) and/or LBW (< 2500 g) infants. Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded, as were studies in which the follow-up period was one week or less.
DATA COLLECTION AND ANALYSIS: Data collection and analysis was performed in accordance with the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS: Nineteen studies enrolling approximately 5000 preterm and/or LBW infants met inclusion criteria. No new trials were identified in May 2013.When all studies were combined, a significant reduction in sepsis was noted (typical risk ratio (RR) 0.85, 95% confidence interval (CI) 0.74 to 0.98; typical risk difference (RD) -0.03, 95% CI 0.00 to -0.05; number needed to treat for an additional beneficial outcome (NNTB) 33, 95% CI 20 to infinity), and moderate between-study heterogeneity was reported (I(2) 54% for RR, 55% for RD). A significant reduction of one or more episodes was found for any serious infection when all studies were combined (typical RR 0.82, 95% CI 0.74 to 0.92; typical RD -0.04, 95% CI -0.02 to -0.06; NNTB 25, 95% CI 17 to 50), and moderate between-study heterogeneity was observed (I(2) 50% for RR, 62% for RD). No statistically significant differences in mortality from all causes were noted (typical RR 0.89, 95% CI 0.75 to 1.05; typical RD -0.01, 95% CI -0.03 to 0.01), and no heterogeneity for RR (I(2) = 21%) or low heterogeneity for RD was documented (I(2) = 28%). No statistically significant difference was seen in mortality from infection; in incidence of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) or intraventricular haemorrhage (IVH) or in length of hospital stay. No major adverse effects of IVIG were reported in any of these studies.
AUTHORS' CONCLUSIONS: IVIG administration results in a 3% reduction in sepsis and a 4% reduction in one or more episodes of any serious infection but is not associated with reductions in other clinically important outcomes, including mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects.The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for conducting additional RCTs to test the efficacy of previously studied IVIG preparations in reducing nosocomial infections in preterm and/or LBW infants.

PMID 23821390
Lauren Young, Jessie Morgan, Felicia M McCormick, William McGuire
Nutrient-enriched formula versus standard term formula for preterm infants following hospital discharge.
Cochrane Database Syst Rev. 2012 Mar 14;3:CD004696. doi: 10.1002/14651858.CD004696.pub4. Epub 2012 Mar 14.
Abstract/Text BACKGROUND: Preterm infants are often growth-restricted at hospital discharge. Feeding infants after hospital discharge with nutrient-enriched formula rather than standard term formula might facilitate "catch-up" growth and improve development.
OBJECTIVES: To determine the effect of feeding nutrient-enriched formula compared with standard term formula on growth and development for preterm infants following hospital discharge.
SEARCH METHODS: We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011, Issue 4), MEDLINE, EMBASE, and CINAHL (to September 2011), conference proceedings and previous reviews.
SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that compared the effect of feeding preterm infants following hospital discharge with nutrient-enriched formula (post-discharge formula or preterm formula) compared with standard term formula.
DATA COLLECTION AND ANALYSIS: We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two review authors.
MAIN RESULTS: We found 15 eligible trials in which a total of 1128 preterm infants participated. The trials were of variable methodological quality with lack of allocation concealment and incomplete follow-up in some trials being the major potential sources of bias. The trials (N = 10) that compared feeding infants with "post-discharge formula" (energy density about 74 kcal/100 ml) versus standard term formula (about 67 kcal/100 ml) did not find consistent evidence of effects on growth parameters up to 12 to 18 months corrected age. The trials (N = 5) that compared feeding with "preterm formula" (about 80 kcal/100 ml) versus term formula found some evidence of higher rates of growth through infancy: weighted mean differences at 12 to 18 months corrected age about 500 g in weight, 5 to10 mm in length, and 5 mm in head circumference. Few trials assessed neurodevelopmental outcomes and these did not detect any statistically significant differences in developmental indices at 18 months corrected age. There are not yet any data on growth or development through later childhood.
AUTHORS' CONCLUSIONS: Current recommendations to prescribe "post-discharge formula" for preterm infants following hospital discharge are not supported by the available evidence. Some limited evidence exists that feeding preterm infants following hospital discharge with "preterm formula" (which is generally only available for in-hospital use) may increase growth rates up to 18 months corrected age.

PMID 22419297
Ga Won Jeon, Yu Jin Jung, Sun Young Koh, Yeon Kyung Lee, Kyung Ah Kim, Son Moon Shin, Sung Shin Kim, Jae Won Shim, Yun Sil Chang, Won Soon Park
Preterm infants fed nutrient-enriched formula until 6 months show improved growth and development.
Pediatr Int. 2011 Oct;53(5):683-8. doi: 10.1111/j.1442-200X.2011.03332.x.
Abstract/Text BACKGROUND: The purpose of the present study was to determine the effect of feeding nutrient-enriched preterm formula to preterm infants until 6 months' corrected age (CA) on growth and development in the first 18 months of life.
METHODS: Very low-birthweight preterm infants were fed preterm formula until term (40 weeks CA). Infants were then assigned to one of three groups and were fed term formula until 6 months' CA (group 1, n= 29); preterm formula to 3 months' CA and then term formula to 6 months' CA (group 2, n= 30); or preterm formula until 6 months' CA (group 3, n= 31). Anthropometry was performed at term, 3, 6, 9, 12, 15, and at s18 months' CA. Mental and psychomotor development were assessed using the Bayley Scales of Infant Development II at 18 months' CA.
RESULTS: Although body weight, length, head circumference and z score for CA at term in group 3 were significantly lower than those of groups 1 and 2, growth rates of these parameters were significantly higher in group 3 up to 18 months CA', as compared to groups 1 and 2. The mental developmental index and psychomotor developmental index of the Bayley test were not significantly different between the three groups.
CONCLUSIONS: Very low-birthweight preterm infants fed nutrient-enriched preterm formula until 6 months' CA demonstrated significantly improved growth rates for bodyweight, length and head circumference, and comparable mental and psychomotor development throughout the first 18 months of life.

© 2011 The Authors. Pediatrics International © 2011 Japan Pediatric Society.
PMID 21342352
Abstract/Text OBJECTIVE: To determine the safety and efficacy of prophylaxis with palivizumab in reducing the incidence of hospitalization because of respiratory syncytial virus (RSV) infection in high-risk infants.
METHODS: A randomized, double-blind, placebo-controlled trial was conducted at 139 centers in the United States, the United Kingdom, and Canada. During the 1996 to 1997 RSV season, 1502 children with prematurity (less than or equal to 35 weeks) or bronchopulmonary dysplasia (BPD) were randomized to receive 5 injections of either palivizumab (15 mg/kg) or an equivalent volume of placebo by intramuscular injection every 30 days. The primary endpoint was hospitalization with confirmed RSV infection. Children were followed for 150 days (30 days from the last injection). Those with hospitalization as a result of RSV infection were evaluated for total number of days in the hospital, total days with increased supplemental oxygen, total days with moderate or severe lower respiratory tract illness, and incidence and total days of intensive care and mechanical ventilation. The incidence of hospitalization for respiratory illness not caused by RSV and the incidence of otitis media were also evaluated. The placebo and palivizumab groups were balanced at entry for demographics and RSV risk factors. Ninety-nine percent of children in both groups completed the protocol and approximately 93% received all five scheduled injections.
RESULTS: Palivizumab prophylaxis resulted in a 55% reduction in hospitalization as a result of RSV (10.6% placebo vs 4.8% palivizumab). Children with prematurity but without BPD had a 78% reduction in RSV hospitalization (8.1% vs 1.8%); children with BPD had a 39% reduction (12.8% vs 7.9%). When gender, entry age, entry weight, BPD, and gestational age were included in a logistic regression model, the effect of prophylaxis with palivizumab remained statistically significant. The palivizumab group had proportionally fewer total RSV hospital days, fewer RSV hospital days with increased oxygen, fewer RSV hospital days with a moderate/severe lower respiratory tract illness, and a lower incidence of intensive care unit admission. Palivizumab was safe and well tolerated. No significant differences were observed in reported adverse events between the two groups. Few children discontinued injections for related adverse events (0.3%). Reactions at the site of injection were uncommon (1.8% placebo vs 2.7% palivizumab); the most frequent reaction was mild and transient erythema. Mild or moderate elevations of aspartate aminotransferase occurred in 1.6% of placebo recipients and 3.6% of palivizumab recipients; for alanine aminotransferase these percentages were 2.0% and 2.3%, respectively. Hepatic and renal adverse events related to the study drug were similar in the two groups.
CONCLUSIONS: Monthly intramuscular administration of palivizumab is safe and effective for prevention of serious RSV illness in premature children and those with BPD.

PMID 9738173

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契約期間が通常12ヵ月のところ、14ヵ月ご利用いただけます。

優待コード: (利用期限:まで)

ご契約はこちらから