Overview

This trial is active, not recruiting.

Condition prematurity
Treatment amino acids
Sponsor Women and Infants Hospital of Rhode Island
Start date November 2008
End date March 2013
Trial size 168 participants
Trial identifier NCT01860573, 08-0089

Summary

The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
amino acids Premasol
(Experimental)
Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
amino acids Premasol

Primary Outcomes

Measure
Rate of weight <10th percentile for age
time frame: 36 weeks post-conceptual age
Rate of length <10th percentile for age
time frame: 36 weeks post-conceptual age
Rate of head circumference <10th percentile for age
time frame: 36 weeks post-conceptual age
Cognitive development score
time frame: 18-22 months corrected gestational age

Secondary Outcomes

Measure
Serum bicarbonate
time frame: Day of life 1, 2, 3, 5 and 7
Serum creatinine
time frame: Day of life 1, 2, 3, 5 and 7
Serum blood urea nitrogen
time frame: Day of life 1, 2, 3, 5 and 7
Serum amino acid profile
time frame: Day of life 3 and 7
Rate of weight <10th percentile for age
time frame: 18-22 months corrected age
Rate of length <10th percentile for age
time frame: 18-22 months corrected age
Rate of head circumference <10th percentile for age
time frame: 18-22 months corrected age

Eligibility Criteria

Male or female participants up to 18 hours old.

Inclusion Criteria: - birth weight 400 to 1250 grams - 24 0/7 to 30 6/7 weeks gestational age Exclusion Criteria: - chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth - infants >18 hours of age - infants in extremis who are unlikely to survive past 72 hours

Additional Information

Principal investigator Joseph M Bliss, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island.