Status:
ACTIVE_NOT_RECRUITING
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
Phase:
NA
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 N...
Eligibility Criteria
Inclusion
- Infant
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04419857
Start Date
December 4 2020
End Date
May 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06512