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Completed
NCT04419857
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Conditions: Neonatal Abstinence Syndrome
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 39
Sponsor: Yale University
Location: Yale New Haven Hospital New Haven Connecticut
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.
Eligibility Criteria
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
Infant Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT04419857). StuddyBuddy aggregates publicly available trial information.