A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximal Percent Weight Loss Compared to Birth Weight
研究概览
简要总结
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
详细描述
The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though women who are not adherent to drug treatment programs or have the potential to use illicit drugs are not able to breastfeed due to the risks posed to the infant. Several studies have demonstrated the potential for caloric enhancement of formula and breast milk to support weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS infants and show that increasing caloric intake can improve weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant Inclusion Criteria:
- •Infants with NAS born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption
- •Infants > 2200 g Infants at least 36 weeks gestational age
- •Delivered at: Yale New Haven Hospital
- •Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits
排除标准
- •Infants with major congenital malformations
- •Infants enrolled to NICU >24 hours for medical conditions other than NAS treatment before 3 days of life
- •Mother's Inclusion criteria -
- •Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
- •Confirm methadone treatment is received from a licensed treatment program
- •Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
- •Confirm that mothers do not intend to place the infant(s) for adoption
- •Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
- •Consent forms will be signed and faxed to study staff
研究组 & 干预措施
High-calorie formula
Infant randomly assigned to high-calorie formula for 14 days
干预措施: High-calorie formula (Dietary Supplement)
Standard calorie formula
Infant randomly assigned to standard-calorie formula for 14 days
结局指标
主要结局
Maximal Percent Weight Loss Compared to Birth Weight
时间窗: 2 weeks
this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight
次要结局
- Median Days to Weight Nadir(2 weeks)
- Number of Participants That Return to Birthweight(1 month)
- Percent Weight Change Per Day(first 7 days after birth)
- Length of Hospital Stay(up to 6.5 days)