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

NCT ID NCT04419857

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

39 people

The number who actually took part.

Started

Dec 2020

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

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