Effectiveness of Donor Human Milk Supplementation Compared to Infant Formula for the Treatment of Hypoglycemia in the Breastfed Infant in the Normal Newborn Nursery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
研究概览
简要总结
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.
详细描述
Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
- •Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
- •Infant with blood glucose after delivery of < 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
- •Deliverying mother plans to exclusively breastfeed.
排除标准
- •Infants born and directly admitted to the newborn intensive care unit
- •Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
- •Infants deemed ward of state
- •Mothers who do not plan to exclusively breastfeed at time of delivery
- •Mothers less than 19 years of age
结局指标
主要结局
Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels
时间窗: Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants.
To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula.
次要结局
- Exclusive Breastfeeding Duration(Families of consented participants will be contacted when the enrolled infant is 6 months old.)
- Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys(Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery).)