Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Study Feasibility_2
研究概览
简要总结
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
详细描述
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age >34 weeks and 0 days
- •Mother's intent to breast feed
- •NICU admission which is predicted to be at least 72 hours from time of admission
排除标准
- •Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
- •Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
- •Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
- •Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
- •Any infant whose care is considered futile by the primary medical team
研究组 & 干预措施
Exclusively Human Milk Diet
This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.
干预措施: Donor Breast Milk (Other)
Formula-based Diet
If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).
结局指标
主要结局
Study Feasibility_2
时间窗: 6-8 weeks chronological age
Feasibility will be evaluated by: study completion rate
Study Feasibility_3
时间窗: 6-8 weeks chronological age
Feasibility will be evaluated by: rate of adherence to the study diet.
Study Feasibility_1
时间窗: 6-8 weeks chronological age
Feasibility will be evaluated by: consent rate
次要结局
- Percentage of Human Milk Consumption at Discharge(at the time of NICU discharge or 7 days of age, whichever is later)
- Breastfeeding duration(6-8 weeks chronological age)
- Growth: Height(6-8 weeks chronological age)
- Percentage of Human Milk Consumption After Discharge(6-8 weeks chronological age)
- Growth: Head Circumference(6-8 weeks chronological age)
- Growth: Weight(6-8 weeks chronological age)
- Intent to Breastfeed(6-8 weeks chronological age)
研究者
Kara L. Calkins, MD
Health Sciences Clinical Assistant Professor, Pediatric Neonatology
University of California, Los Angeles