drugset / Trial / NCT01860573
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2013-03
- Completion
- 2016-12
Publications
- Background 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. doi: 10.1016/j.jpeds.2005.10.038.
- Background 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.
- Background 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. doi: 10.1203/00006450-200301000-00008.
- Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | amino acids | Unknown | 4 g/kg | — |
Indications
No indication recorded.