Early Limited Formula for Treating Lactation Concerns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 4
- 主要终点
- Length of breastfeeding duration
研究概览
简要总结
This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
- •Exclusively breastfeeding (has not received any feedings other than breast milk)
- •Infant is 18-72 hours old
- •Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
- •English-speaking mother
排除标准
- •Mothers or infants for whom breastfeeding is not recommended by the clinical team
- •Mothers who have already begun to produce mature breast milk
- •Any formula or water feeding prior to enrollment
- •Infants who have already lost ≥10% of their birth weight
- •Family with no active telephone number (home or cellular)
- •Plan for infant adoption or foster care
- •Mothers <18 years of age
- •Infant receiving scoring for Narcotic Abstinence Syndrome -
研究组 & 干预措施
Early Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
干预措施: Early Limited Formula (Other)
Standard Care
Continue exclusive breastfeeding unless otherwise instructed by a health care provider
干预措施: Standard Care (Other)
结局指标
主要结局
Length of breastfeeding duration
时间窗: 12 months
The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
次要结局
- State Trait Anxiety Inventory(1 month)
- Health care utilization(1 month)
- Formula use(6 months)
研究者
Valerie Flaherman
Associate Professor of Pediatrics and Epidemiology and Biostatistics
University of California, San Francisco