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Completed

NCT Number: NCT04419857

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

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-calorie formula

Dietary Supplement

Infant randomly assigned to high-calorie formula for 14 days

Primary outcomes

  1. Maximal Percent Weight Loss Compared to Birth Weight

    Time frame: 2 weeks

    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

Secondary outcomes

  1. Median Days to Weight Nadir

    Time frame: 2 weeks

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

  2. Number of Participants That Return to Birthweight

    Time frame: 1 month

    Number of participants that regained birthweight, assessed within the first month after birth

  3. Percent Weight Change Per Day

    Time frame: first 7 days after birth

    Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first 7 days after birth

  4. Length of Hospital Stay

    Time frame: up to 6.5 days

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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