A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

Yale University

Status

Active, not recruiting

Conditions

Neonatal Abstinence Syndrome

Treatments

Dietary Supplement: High-calorie formula

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04419857

2T35DK104689-06 (U.S. NIH Grant/Contract)

2000028252

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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