N/A
N=168
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT01860573 ↗Enrolled (actual)
168
Serious AEs
29.8%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Weight<10th Percentile for Age — 32; 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amino acids (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Women and Infants Hospital of Rhode Island
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Weight<10th Percentile for Age |
32; 41 | — |
| PRIMARY Number of Participants With Length <10th Percentile for Age |
29; 42 | — |
| PRIMARY Number of Participants With Head Circumference <10th Percentile for Age |
20; 23 | — |
| PRIMARY Cognitive Development Score |
90.2; 90.6 | — |
| SECONDARY Serum Bicarbonate |
21.2; 21.8; 20.7; 21.2; 20.0; 20.1 | — |
| SECONDARY Serum Creatinine |
.99; .97; 1.11; 1.11; 1.16; 1.10 | — |
| SECONDARY Serum Blood Urea Nitrogen |
19.0; 21.6; 26.1; 35.8; 29.8; 43.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01860573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.