Could a simple formula change help babies born dependent on opioids gain weight better?

NCT ID NCT04419857

Completed Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether newborns with neonatal abstinence syndrome (NAS) who receive a high-calorie formula for two weeks gain weight better than those on standard formula. The babies are managed using the Eat, Sleep, Console approach. The main goal is to see how much weight they lose after birth and how quickly they regain it.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: high-calorie infant formula
What this could lead to: If it works, this could point toward a simple dietary change to improve weight gain in newborns withdrawing from opioids.
What could go wrong: This is a small, early-stage trial, so results may not apply to all infants. High-calorie formula may not significantly improve weight outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NEONATAL ABSTINENCE SYNDROME

Contacts and locations

Locations

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.