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A Randomized Control 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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Yale New Haven Hospital
New Haven, Connecticut, United States
Start Date
December 4, 2020
Primary Completion Date
May 1, 2025
Completion Date
May 1, 2026
Last Updated
July 22, 2025
39
ACTUAL participants
High-calorie formula
DIETARY_SUPPLEMENT
Lead Sponsor
Yale University
Collaborators
NCT04783558
NCT05129020
Data Source & Attribution
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