Clinical trial NCT04419857: A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Official title: A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Keywords: high-caloric diet regimens
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-06-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Maximal percent weight loss compared to birth weight
timeFrame: 2 weeks
Secondary outcomes:
measure: Hours to weight nadir
timeFrame: 2 weeks
measure: Days to return to birthweight
timeFrame: 1 month
measure: Percent weight change per day
timeFrame: 2 weeks
measure: Length of hospital stay
timeFrame: up to 6.5 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Matthew Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References: