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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-04

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Abstinence Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High-calorie formula

Infant randomly assigned to high-calorie formula for 14 days

Group Type EXPERIMENTAL

High-calorie formula

Intervention Type DIETARY_SUPPLEMENT

Infant randomly assigned to high-calorie formula for 14 days

Standard calorie formula

Infant randomly assigned to standard-calorie formula for 14 days

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-calorie formula

Infant randomly assigned to high-calorie formula for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No