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The ProVIDe study: the impact of protein intravenous nutrition on development in extremely low birthweight babies
Frank H Bloomfield1,2,3,4,5, Caroline A Crowther6,7, Jane E Harding8
1Liggins Institute, The University of Auckland, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.
Insights
This study investigated if extra protein for extremely low birthweight babies improves neurodevelopment. Results will inform optimal neonatal nutrition for better growth and reduced disability.
Area of Science:
- Neonatal Medicine
- Developmental Pediatrics
- Nutritional Science
Background:
- Preterm birth and low birthweight significantly impact long-term neurodevelopment and growth.
- While increased neonatal protein intake is recommended, the optimal amount remains unknown.
- Up to 50% of extremely low birthweight infants experience neurodevelopmental or learning disabilities.
Purpose of the Study:
- To assess if an additional 1-2 g/kg/day of protein in the first 5 days improves neurodevelopmental outcomes and growth in extremely low birthweight babies.
- To provide evidence on the optimal intravenous protein supplementation for preterm infants.
Main Methods:
- A multicentre, double-blind, randomised controlled trial (ProVIDe study) involving 430 infants with birthweight < 1000g.
- Infants received either an amino acid solution or placebo intravenously for the first 5 days.
- Exclusion criteria included late NICU admission, multiple births (>2), chromosomal abnormalities, and imminent death.
Main Results:
- The study is designed to evaluate growth at multiple time points (birth to 2 years corrected age) and body composition.
- Secondary outcomes include neonatal morbidity, length of stay, and nutritional intake.
- The primary outcome is survival free from neurodevelopmental disability at 2 years corrected age.
Conclusions:
- This trial will offer the first direct evidence on the impact of higher early intravenous protein intake on neurodevelopmental outcomes at 2 years corrected age.
- Findings will guide clinical practice regarding neonatal nutrition for extremely low birthweight infants.
Background:
Preterm birth and very small size at birth have long-term effects on neurodevelopment and growth. A relatively small percentage of extremely low birthweight babies suffer from severe neurological disability; however, up to 50% experience some neurodevelopmental or learning disability in childhood. Current international consensus is that increased protein intake in the neonatal period improves both neurodevelopment and growth, but the quantum of protein required is not known. This trial aims to assess whether providing an extra 1 to 2 g.kg(-1).d(-1) protein in the first 5 days after birth will improve neurodevelopmental outcomes and growth in extremely low birthweight babies.
Methods/Design:
The ProVIDe study is a multicentre, two-arm, double-blind, parallel, randomised, controlled trial. In addition to standard intravenous nutrition, 430 babies with a birthweight of less than 1000 g who have an umbilical arterial line in situ will be randomised in 1:1 ratio to receive either an amino acid solution (TrophAmine®) or placebo (saline) administered through the umbilical arterial catheter for the first 5 days. Exclusion criteria are admission to neonatal intensive care more than 24 h after birth; multiple births of more than 2 babies; known chromosomal or genetic abnormality, or congenital disorder affecting growth; inborn error of metabolism, and in danger of imminent death.
Primary Outcome:
Survival free from neurodevelopmental disability at 2 years' corrected age, where neurodevelopmental disability is defined as cerebral palsy, blindness, deafness, developmental delay (standardised score more than 1 SD below the mean on the cognitive, language or motor subscales of the Bayley Scales of Infant Development Edition 3), or Gross Motor Function Classification System score ≥ 1.
Secondary Outcomes:
Growth, from birth to 36 weeks' corrected gestational age, at neonatal intensive care discharge and at 2 years' corrected age; body composition at 36 to 42 weeks' corrected postmenstrual age and at 2 years' corrected age; neonatal morbidity, including length of stay; nutritional intake.
Discussion:
This trial will provide the first direct evidence of the effects of giving preterm babies a higher intake of intravenous protein in the first week after birth on neurodevelopmental outcomes at 2 years corrected age.
Trial Registration:
Australian New Zealand Clinical Trials Registry: ACTRN12612001084875.
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