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The ProVIDe study: the impact of protein intravenous nutrition on development in extremely low birthweight babies

BMC Pediatrics
Q2
Aug 2015
Citations:23
Influential Citations:0
Interventional (Human) Studies
81
COI
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Enhanced Details

Methods
Multicentre randomized 1:1 trial in extremely low birthweight preterm infants with birthweight <1000 g and a functioning umbilical arterial catheter. The study population was enrolled in New Zealand and all infants received standard NICU nutrition plus either the amino acid infusion or saline.
Intervention
The active regimen was an intravenous amino acid infusion using 8.5% TrophAmine® delivered through the umbilical arterial catheter at 0.5 mL/h for 120 h after birth. This provided approximately an extra 1 g of protein in 12 mL, or about 1 to 2 g/kg/day of additional protein above standard intravenous nutrition; the comparator was saline.
Results
No outcome results were provided in the source packet. The study was designed to test whether extra early intravenous protein during the first 5 days after birth improves survival free from neurodevelopmental disability at 2 years' corrected age in extremely low birthweight infants, with additional evaluation of growth, body composition, neonatal morbidity, and nutritional intake. The authors' stated premise was that positive findings could support a simple, low-cost change in neonatal nutrition practice.
Limitations
The source packet provides a study rationale and protocol-level details rather than reported efficacy results, so treatment effect cannot be assessed from the available information. The main endpoint is long-term neurodevelopmental status at 2 years' corrected age, which is important but not yet reported here; enrollment period and setting details are also limited.

Abstract

No abstract available