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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
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 moreTrial 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
1,907 Previous Clinical Trials
3,018,949 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,791 Total Patients Enrolled
Matthew Grossman, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born at or after 36 weeks of pregnancy.My baby weighs more than 2200 grams.I am a pregnant woman aged 18-45 and have started methadone treatment.My baby has NAS and I was exposed to methadone during pregnancy. I am between 18-45 years old and not planning to give my baby up for adoption.I receive methadone from a licensed program.I, as a mother, am willing to join the study and attend follow-up weigh-ins.I can visit my child's doctor for weight checks at 2 and 4 months.My infant was in the NICU for more than a day for reasons other than NAS treatment within their first 3 days.Newborns with serious birth defects.
Research Study Groups:
This trial has the following groups:- Group 1: High-calorie formula
- Group 2: Standard calorie formula
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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