Prematurity Clinical Trial
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.
Status | Active, not recruiting |
Enrollment | 168 |
Est. completion date | December 2016 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Hours |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island |
United States,
Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305. — View Citation
Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211. — View Citation
Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of weight <10th percentile for age | 36 weeks post-conceptual age | Yes | |
Primary | Rate of length <10th percentile for age | 36 weeks post-conceptual age | Yes | |
Primary | Rate of head circumference <10th percentile for age | 36 weeks post-conceptual age | Yes | |
Primary | Cognitive development score | 18-22 months corrected gestational age | Yes | |
Secondary | Serum bicarbonate | Day of life 1, 2, 3, 5 and 7 | Yes | |
Secondary | Serum creatinine | Day of life 1, 2, 3, 5 and 7 | Yes | |
Secondary | Serum blood urea nitrogen | Day of life 1, 2, 3, 5 and 7 | Yes | |
Secondary | Serum amino acid profile | Day of life 3 and 7 | Yes | |
Secondary | Rate of weight <10th percentile for age | 18-22 months corrected age | Yes | |
Secondary | Rate of length <10th percentile for age | 18-22 months corrected age | Yes | |
Secondary | Rate of head circumference <10th percentile for age | 18-22 months corrected age | Yes |
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