NCT04419857

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High-calorie formula	Infant randomly assigned to high-calorie formula for 14 days

Timeline

• Start date: 2020-12-04
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2020-06-05
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States