Jon Dorling (Nottingham University Hospitals NHS Trust, Nottingham, UK)
Ben Stenson (Simpson Centre for Reproductive Health, Edinburgh), Tracy Roberts (University of Birmingham), William McGuire (University of York), Kenny McCormick (Oxford Radcliffe Hospitals NHS Trust), Alison Leaf (University of Southampton), Samantha Johnson (University of Leicester), Nicholas Embleton (Royal Victoria Infirmary, Newcastle), Elaine Boyle (University of Leicester), Janet Berrington (Royal Victoria Infirmary, Newcastle), Jane Abbott (Bliss (PPI), London), Ed Juszczak (NPEU), Louise Linsell (NPEU)
Care of the preterm or low birthweight infant, Preterm birth
National Institute for Health Research Health Technology Assessment Programme
Very preterm babies are unable to tolerate nutritional volumes of milk without complications so require parenteral nutrition whilst milk feeds are built up.
The best speed of increasing these feeds to achieve full milk feeds without causing complications is not yet known and a trial is needed to determine this balance.
Short and long-term outcomes for preterm babies are affected by strategies that reduce infection rates, reduce necrotising enterocolitis (NEC) rates, promote adequate growth, and encourage earlier discharge.
Feeding strategies impact on all of these and this study will examine two rates of increasing milk feeds with a primary focus of determining the effect on rate of survival without moderate or severe disability.
In a multi-centre RCT, we aim to assess whether a fast (30mls/kg/day) compared to a slow (18mls/kg/day) daily increase in milk feed volumes in very low birthweight infants (under 1500g at birth) or significantly preterm infants (born before 32 weeks of gestation) results in:
An increase in survival without serious disability at 24 months of age corrected for prematurity [Primary objective]
A reduction in the incidence of invasive nosocomial infection before hospital discharge, reduced time to reach full milk feeds; improved growth; reduced duration of parenteral feeding; reduced length of time in intensive care; reduced length of hospital stay; no increase in the incidence of necrotising enterocolitis; [Secondary objectives]
Beneficial economic evaluation as judged by incremental costs estimate for statistically significant differences in these outcomes [Secondary objective]