Preventing Infant Malnutrition with Early Supplementation (PRIMES)
收藏osf.io2024-02-20 更新2025-03-23 收录
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The PRIMES (Study 3) is a randomized clinical trial enrolling infants (n=324; 162 per site) in Guinea-Bissau and Uganda weighing ≥2000g at birth. Infants are randomized to one of two groups: 1) Early Small-Volume Supplementation (ESVS intervention group), which consists of up to 59 mL formula administered daily after breastfeeding through 30 days of age followed by exclusive breastfeeding through 6 months of age; or 2) frequent exclusive breastfeeding (EBF control) without any food or fluid other than vitamins, minerals and medications through 6 months of age.
The proposed study will test the efficacy of early small-volume supplementation (ESVS) for increasing weight-for-age z-score (WAZ) at 1 month of age.
Preregistration
https://clinicaltrials.gov/ct2/show/NCT04704076
PRIMES（研究3）是一项随机临床试验，招募了来自几内亚比绍和乌干达的婴儿（n=324；每个地点162名），这些婴儿出生时体重≥2000g。婴儿被随机分配到两个组别之一：1）早期小剂量补充（ESVS干预组），该组别包括每日在母乳喂养后通过59毫升配方奶的补充，直至婴儿30天大，随后进行6个月的纯母乳喂养；或2）频繁的纯母乳喂养（EBF对照组），在6个月大之前不接受任何食物或液体，仅包括维生素、矿物质和药物。本研究旨在检验早期小剂量补充（ESVS）对1个月大婴儿体重与年龄Z分数（WAZ）增加的疗效。
预先注册
https://clinicaltrials.gov/ct2/show/NCT04704076
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