ACTIVE_NOT_RECRUITING

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

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Conditions

Neonatal Abstinence Syndromehigh-caloric diet regimens

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-12-04
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04419857

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Infants \> 2200 g Infants at least 36 weeks gestational age
  3. * Delivered at: Yale New Haven Hospital
  4. * Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits
  1. * Infants with major congenital malformations
  2. * Infants enrolled to NICU \>24 hours for medical conditions other than NAS treatment before 3 days of life
  3. * Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
  4. * Confirm methadone treatment is received from a licensed treatment program
  5. * Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
  6. * Confirm that mothers do not intend to place the infant(s) for adoption
  7. * Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
  8. * Consent forms will be signed and faxed to study staff

Contacts and Locations

Principal Investigator

Matthew Grossman, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Yale University

  • Matthew Grossman, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-04
Study Completion Date2026-05

Study Record Updates

Study Start Date2020-12-04
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • high-caloric diet regimens

Additional Relevant MeSH Terms

  • Neonatal Abstinence Syndrome