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

N/AActive Not RecruitingNCT04419857

Yale University39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neonatal Abstinence Syndrome

Interventions

High-calorie formulaDIETARY_SUPPLEMENT

Infant randomly assigned to high-calorie formula for 14 days

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Maximal percent weight loss compared to birth weight

this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight

Time frame: 2 weeks

Secondary Outcomes

Hours to weight nadir

Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth

Time frame: 2 weeks

Days to return to birthweight

Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth

Time frame: 1 month

Percent weight change per day

Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth

Time frame: 2 weeks

Length of hospital stay

Measured by comparing admission time to discharge time, assessed at hospital discharge

Time frame: up to 6.5 days

Data from ClinicalTrials.gov

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