A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Dietary Supplement: High-calorie formula
- Registration Number
- NCT04419857
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
Infant
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-calorie formula High-calorie formula Infant randomly assigned to high-calorie formula for 14 days
- Primary Outcome Measures
Name Time Method Maximal percent weight loss compared to birth weight 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
- Secondary Outcome Measures
Name Time Method Length of hospital stay up to 6.5 days Measured by comparing admission time to discharge time, assessed at hospital discharge
Percent weight change per day 2 weeks Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth
Hours to weight nadir 2 weeks Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth
Days to return to birthweight 1 month Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth
Trial Locations
- Locations (1)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States