RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants

Completed · Phase 2

Conditions studied: Neonatal Abstinence Syndrome

In brief

Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.

Key facts

Study ID

NCT02178189

Run by

University of Pittsburgh

People needed

85

Starts

2010-04-01

Expected to finish

2013-12-01

Last updated by the study team

2014-06-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born to pregnant women, who are 18 to 45 years of age, participating in a licensed methadone maintenance treatment program
• planning to delivered at Magee if consented during pregnancy or delivered at Magee within the past 48 hours

You may not qualify if…

• Infants born weighing <2200 grams or before 35 weeks
• Multiple gestation pregnancies (eg. twins)
• Infants with major congenital malformations that could interfere with feeding or weight gain, such as Downs syndrome, cleft lip or palate, congenital heart disease or cystic fibrosis will be excluded.
• Infants admitted to the NICU longer than 48 hours for a medical condition other than treatment of NAS
• Women who do not speak English will be excluded because study staff will not be able to communicate effectively.
• Women who intend to place their infant for adoption
• Women who plan on feeding their baby soy formula from birth

Where it is running

• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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