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

NCT02178189 | Completed Phase 2

• 2 other identifiers: PRO09120457R21DA029257
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

prenatal opioid exposure; infant; weight gain; infant formula

Outcome Measures

Primary Outcomes (1)

• Weight Patterns (gain and loss)

  Weight loss and gain patterns will include days to return to birth weight, days to weight nadir (lowest point) and maximum percent weight loss.

  Up to 3 weeks

Secondary Outcomes (1)

• Neonatal abstinence syndrome (NAS) severity measures

  Up to 3 weeks

Study Arms (2)

Standard-calorie infant formula

ACTIVE COMPARATOR

Infants assigned to this arm were fed standard-calorie infant formula (20 kcal/oz) from 72 hours of life until 21 days of age.

Other: Standard Calorie Infant Formula

High-calorie infant formula

EXPERIMENTAL

Infants assigned to this arm were fed high-calorie infant formula (24 kcal/oz) from 72 hours of life until 21 days of age.

Other: High Calorie Infant formula

Interventions

High Calorie Infant formula OTHER

Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.

High-calorie infant formula

Standard Calorie Infant Formula OTHER

Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.

Standard-calorie infant formula

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Weight Gain

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra L Bogen, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

US (1)