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