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

Neonatal Abstinence Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04419857
Study type Interventional
Source Yale University
Contact Lisa Palmieri, BA
Phone 203-785-4651
Email lisa.palmieri@yale.edu
Status Recruiting
Phase N/A
Start date December 4, 2020
Completion date May 2026
View Details
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