University of Washington, Seattle, WA, United States of America.
International Partnership for Human Development, Bissau, Guinea-Bissau.
PLoS One. 2022 Feb 4;17(2):e0263129. doi: 10.1371/journal.pone.0263129. eCollection 2022.
Childhood undernutrition is a major health burden worldwide that increases childhood morbidity and mortality and causes impairment in infant growth and developmental delays that can persist into adulthood. The first weeks and months after birth are critical to the establishment of healthy growth and development during childhood. The World Health Organization recommends immediate and exclusive breastfeeding (EBF). In infants for whom EBF may not meet nutritional and caloric demands, early, daily, small-volume formula supplementation along with breastfeeding may more effectively avoid underweight wasting and stunting in early infancy than breastfeeding alone. The primary objective of this randomized controlled trial is to evaluate the efficacy of formula for 30 days among low birth weight (LBW) infants <6 hours of age and those not LBW with weights <2600 grams at 4 days of age. We will compare breastfeeding and formula (up to 59 milliliters administered daily) through 30 days of infant age vs recommendations for frequent EBF without supplementation, and test the hypothesis that formula increases weight-for-age z-score at 30 days of infant age. The trial will enroll and randomize 324 mother-infant pairs in Guinea-Bissau and Uganda, and follow them for 6 months for outcomes including growth, intestinal microbiota, breastfeeding duration, infant dietary intake, and adverse events. Conservatively estimating 20% loss to follow up, this sample size provides ≥80% power per weight stratum for intervention group comparison to detect a difference of 0.20 with respect to the outcome of WAZ at day 30. This trial was approved by the University of California, San Francisco Institutional Review Board (19-29405); the Guinea-Bissau National Committee on Ethics in Health (Comite Nacional de Etica na Saude, 075/CNES/INASA/2020); the Higher Degrees, Research and Ethics Committee of Makerere University (871); and the Uganda National Council of Science and Technology (HS1226ES). We plan to disseminate study results in peer-reviewed journals and international conferences. Trial registration number: NCT04704076.
儿童期营养不良是全球范围内的一个主要健康负担，它会增加儿童的发病率和死亡率，并导致婴儿生长受损和发育迟缓，这些问题可能会持续到成年期。婴儿出生后的头几周和几个月对其在儿童期的健康成长和发育至关重要。世界卫生组织建议立即并完全进行母乳喂养（EBF）。对于那些 EBF 可能无法满足营养和热量需求的婴儿，早期、每日、小剂量配方奶补充喂养与母乳喂养相结合，可能比单独母乳喂养更有效地避免婴儿早期体重不足、消瘦和发育迟缓。这项随机对照试验的主要目的是评估配方奶在 6 小时以下的低出生体重（LBW）婴儿和出生后 4 天体重<2600 克的非 LBW 婴儿中的 30 天疗效。我们将通过 30 天的婴儿年龄比较母乳喂养和配方奶（每天最多 59 毫升）与不补充的频繁 EBF 建议，并检验配方奶可增加婴儿 30 天龄时体重年龄 Z 评分的假设。该试验将在几内亚比绍和乌干达招募和随机分配 324 对母婴对，并对其进行 6 个月的随访，以评估包括生长、肠道微生物群、母乳喂养持续时间、婴儿饮食摄入和不良事件在内的结局。保守估计 20%的失访率，这个样本量为每组提供了≥80%的效力，以便对干预组进行比较，以检测在第 30 天体重 Z 评分方面的差异为 0.20。这项试验已获得加利福尼亚大学旧金山分校机构审查委员会（19-29405）、几内亚比绍国家卫生伦理委员会（Comite Nacional de Etica na Saude，075/CNES/INASA/2020）、马凯雷雷大学高级学位、研究和伦理委员会（871）和乌干达国家科学技术委员会（HS1226ES）的批准。我们计划在同行评议期刊和国际会议上传播研究结果。试验注册号：NCT04704076。
