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

Description

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

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Study Overview

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Study Details

Study 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.

A Randomized Control 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

Condition
Neonatal Abstinence Syndrome
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Matthew Grossman, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-05