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Dietary Supplement

High-Calorie Formula for Neonatal Abstinence Syndrome

N/A
Recruiting
Led By Matthew Grossman, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants > 2200 g
Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial studied whether a high-calorie diet helps babies with NAS gain weight.

Who is the study for?
This trial is for NAS infants born to mothers aged 18-45 who used methadone during pregnancy. The babies must be at least 36 weeks gestational, over 2200 grams, and not placed for adoption. They should be delivered at Yale New Haven Hospital with plans to attend follow-up visits.
What is being tested?
The study tests if a high-calorie formula can help NAS infants gain weight better than standard formula. Infants are randomly assigned to one of the two feeding regimens while being managed via the Eat, Sleep, Console approach.
What are the potential side effects?
While specific side effects aren't listed here, high-calorie formulas may sometimes cause gastrointestinal issues like gas or constipation in some infants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby weighs more than 2200 grams.
Select...
I am a pregnant woman aged 18-45 and have started methadone treatment.
Select...
I receive methadone from a licensed program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximal percent weight loss compared to birth weight
Secondary study objectives
Days to return to birthweight
Hours to weight nadir
Length of hospital stay
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-calorie formulaExperimental Treatment1 Intervention
Infant randomly assigned to high-calorie formula for 14 days
Group II: Standard calorie formulaActive Control1 Intervention
Infant randomly assigned to standard-calorie formula for 14 days

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,374 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,353 Total Patients Enrolled
Matthew Grossman, MDPrincipal InvestigatorYale University

Media Library

High-calorie formula (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04419857 — N/A
Neonatal Abstinence Syndrome Research Study Groups: High-calorie formula, Standard calorie formula
Neonatal Abstinence Syndrome Clinical Trial 2023: High-calorie formula Highlights & Side Effects. Trial Name: NCT04419857 — N/A
High-calorie formula (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419857 — N/A
~8 spots leftby May 2025
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