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

NCT04419857 | Active Not Recruiting DMC

• 2 other identifiers: 20000282522T35DK104689-06
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

high-caloric diet regimens

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (4)

• Hours to weight nadir

  2 weeks

• Days to return to birthweight

  1 month

• Percent weight change per day

  2 weeks

• Length of hospital stay

  up to 6.5 days

Study Arms (2)

High-calorie formula

EXPERIMENTAL

Infant randomly assigned to high-calorie formula for 14 days

Dietary Supplement: High-calorie formula

Standard calorie formula

NO INTERVENTION

Infant randomly assigned to standard-calorie formula for 14 days

Interventions

High-calorie formula DIETARY_SUPPLEMENT

Infant randomly assigned to high-calorie formula for 14 days

High-calorie formula

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infants with major congenital malformations
• Infants enrolled to NICU \>24 hours for medical conditions other than NAS treatment before 3 days of life
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Matthew Grossman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: December 4, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)