RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
NCT ID: NCT02178189
Last Updated: 2014-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2010-04-30
2013-12-31
Brief Summary
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Detailed Description
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Specific Aims:
1. For methadone exposed infants, compare infants randomized to high (24 kcal/oz) versus standard (20 kcal/oz) formula for the following outcomes:
* Weight loss and gain patterns. The primary dependent measure will be days until the infant returns to birth weight. Secondary measures will be maximum percent weight loss and days to weight nadir.
* NAS severity measured by: a) total length of hospital stay for NAS; b) duration of NAS treatment; c) mean Finnegan scores on days 2-10; d) maximum concentration of morphine used to treat NAS.
2. Describe the suck quality at 4-6 days of age among methadone exposed infants. Evaluate the association between the infant suck quality and infant weight loss and gain patterns and measures of NAS severity.
Design: Women on methadone will be recruited during pregnancy and will attend a single brief visit late in pregnancy. After delivery, infants will be randomized in a double blind trial of either high-calorie or standard-calorie formula which will be started at 72 hours after birth and be continued through 21 days of age. Infants will be weighed daily and will have outpatient study visits at 1 and 3 months. For this pilot study, up to 70 mothers will be enrolled over 18 months. This pilot study is needed to establish the feasibility of the study methods and to better estimate differences that can be observed between the groups. For the primary outcome variable, days until the infant returns to birth weight, discrete survival methods will be used.
Potential Impact: Early caloric enhancement for methadone-exposed infants is inexpensive, readily available, easy to implement and could improve outcomes of these high-risk infants. High-calorie formula could result in a more normal pattern of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard-calorie infant formula
Infants assigned to this arm were fed standard-calorie infant formula (20 kcal/oz) from 72 hours of life until 21 days of age.
Standard Calorie Infant Formula
Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.
High-calorie infant formula
Infants assigned to this arm were fed high-calorie infant formula (24 kcal/oz) from 72 hours of life until 21 days of age.
High Calorie Infant formula
Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.
Interventions
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High Calorie Infant formula
Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.
Standard Calorie Infant Formula
Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.
Eligibility Criteria
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Inclusion Criteria
* planning to delivered at Magee if consented during pregnancy or delivered at Magee within the past 48 hours
Exclusion Criteria
* 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
1 Day
3 Days
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Debra L. Bogen
Associate Professor of Pediatrics
Principal Investigators
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Debra L Bogen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO09120457
Identifier Type: -
Identifier Source: org_study_id