None listed
Conditions
Brief summary
Postnatal growth restriction, or faltering growth, is almost universal in extremely low birthweight (ELBW) babies. This is largely due to inadequate nutrition, as it is very difficult to maintain nutritional intake in the smallest babies, particularly in the first week after birth. ELBW babies are also at risk of adverse neurodevelopmental outcomes, likely also due, in part, to inadequate nutrition. We have shown that increasing protein intakes in early life prevents faltering growth. We now propose to determine whether increased protein intake in early life in ELBW babies improves neurodevelopmental outcomes through a multicentre, double-blind randomised placebo-controlled trial. The findings of this trial will be of relevance to the management of all preterm babies because the intervention is simple and cheap.
Interventions
All babies will receive intravenous nutrition according to NICU practices. In addition, babies will be randomised to the intervention or placebo control:
Intervention group: Babies will receive 8.5% intravenous amino acid solution at 0.5 mL/hr via the umbilical arterial catheter (UAC), providing an additional 1 to 2 g/Kg.d protein for 5 days. If the UAC is required for longer than 5 days, the solution will be changed to 0.45% saline.
Sponsors
Professor Frank Bloomfield
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 24 Hours
Healthy volunteers
No
Inclusion criteria
Babies <1,000 g at birth and admitted to NICU with a UAC placed.
Exclusion criteria
Birth weight greater than or equal to 1000 g; admission to NICU >24 hours after birth; multiple birth >2 children; congenital disorder affecting growth; inborn error of metabolism; in danger of imminent death.
Outcome results
None listed