Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
Overview
- Phase
- N/A
- Intervention
- Amino acids
- Conditions
- Prematurity
- Sponsor
- Women and Infants Hospital of Rhode Island
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Number of Participants With Weight<10th Percentile for Age
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Joseph Bliss
Staff Neonatologist
Women and Infants Hospital of Rhode Island
Eligibility 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
Arms & Interventions
Standard amino acids
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
Intervention: Amino acids
High amino acids
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
Intervention: Amino acids
Outcomes
Primary Outcomes
Number of Participants With Weight<10th Percentile for Age
Time Frame: 36 weeks post-conceptual age
Number of Participants With Length <10th Percentile for Age
Time Frame: 36 weeks post-conceptual age
Number of Participants With Head Circumference <10th Percentile for Age
Time Frame: 36 weeks post-conceptual age
Cognitive Development Score
Time Frame: 18-22 months corrected gestational age
Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.
Secondary Outcomes
- Serum Creatinine(Day of life 1, 2, 3, 5 and 7)
- Serum Blood Urea Nitrogen(Day of life 1, 2, 3, 5 and 7)
- Serum Bicarbonate(Day of life 1, 2, 3, 5 and 7)