Bogen Debra L, Hanusa Barbara H, Baker Robyn, Medoff-Cooper Barbara, Cohlan Barbara
Divisions of General Academic Pediatrics and
Divisions of General Academic Pediatrics and.
Hosp Pediatr. 2018 Jan;8(1):7-14. doi: 10.1542/hpeds.2017-0114.
Newborns who are prenatally exposed to methadone are at risk for neonatal abstinence syndrome and the associated excess weight loss and poor weight gain. This pilot feasibility study aimed to evaluate early caloric enhancement on weight patterns among infants born to women receiving methadone maintenance therapy while pregnant.
In this double-blind pilot feasibility study, we randomly assigned infants with fetal methadone exposure to 24 or 20 kcal/oz formula from days 3 to 21. Randomization was stratified by any breastfeeding, sex of the infant, and gestational age. Eligible infants were ≥35 weeks' gestation and weighed ≥2200 g. Outcomes were days to weight nadir, maximum percent weight loss, days to birth weight, percentage weight change per day, and feasibility.
A total of 49 infants were randomly assigned (22 to standard- and 27 to high-calorie formula); groups had comparable demographic characteristics. Main outcomes comparing standard- to high-calorie formula groups were not significant (days to weight nadir, 5.0 vs 4.4 days; = .20; maximum percent weight loss, -9.4% vs -8.6%; = .15; days to birth weight, 14.7 vs 13.6 days; = .07); however, in longitudinal analyses (days 4 to 21), the high-calorie group had a higher percent weight gained per day compared with the standard-calorie group ( <.001). There were high levels of protocol adherence, and no adverse effects were observed.
Study findings suggest that early initiation of high-calorie formula for infants with prenatal methadone exposure may be beneficial for weight gain; evaluation in a larger study is warranted.
产前暴露于美沙酮的新生儿有发生新生儿戒断综合征以及相关体重过度减轻和体重增加不佳的风险。这项初步可行性研究旨在评估在孕期接受美沙酮维持治疗的妇女所生婴儿中，早期热量增加对体重模式的影响。
在这项双盲初步可行性研究中，我们将产前暴露于美沙酮的婴儿从出生第3天至第21天随机分为接受24千卡/盎司配方奶组或20千卡/盎司配方奶组。随机分组按是否进行母乳喂养、婴儿性别和胎龄进行分层。符合条件的婴儿胎龄≥35周，体重≥2200克。观察指标包括达到体重最低点的天数、最大体重减轻百分比、恢复出生体重的天数、每日体重变化百分比以及可行性。
共有49名婴儿被随机分组（22名接受标准配方奶，27名接受高热量配方奶）；两组的人口统计学特征具有可比性。比较标准配方奶组和高热量配方奶组的主要观察指标无显著差异（达到体重最低点的天数，5.0天对4.4天；P = 0.20；最大体重减轻百分比，-9.4%对-8.6%；P = 0.15；恢复出生体重的天数，14.7天对13.6天；P = 0.07）；然而，在纵向分析（第4天至第21天）中，高热量组每日体重增加百分比高于标准热量组（P<0.001）。方案依从性高，未观察到不良反应。
研究结果表明，对于产前暴露于美沙酮的婴儿，早期开始使用高热量配方奶可能有利于体重增加；有必要在更大规模的研究中进行评估。
