Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
Information source: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prematurity
Intervention: Amino acids (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Women and Infants Hospital of Rhode Island Official(s) and/or principal investigator(s):
Joseph M Bliss, MD, PhD, Principal Investigator, Affiliation: Women and Infants Hospital of Rhode Island
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Rate of weight <10th percentile for ageRate of length <10th percentile for age Rate of head circumference <10th percentile for age Cognitive development score
Secondary outcome: Serum bicarbonateSerum creatinine Serum blood urea nitrogen Serum amino acid profile Rate of weight <10th percentile for age Rate of length <10th percentile for age Rate of head circumference <10th percentile for age
Eligibility
Minimum age: N/A.
Maximum age: 18 Hours.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States
Additional Information
Related publications: 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. 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. 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.
Starting date: November 2008
Last updated: March 17, 2015
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