A multi-centre randomised controlled trial of two speeds of daily increment of milk feeding in very preterm or very low weight infants.
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 rate 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.
Infants will be randomly allocated to receive either a fast (30 ml/kg/day) or slow (18 ml/kg/day) increase in milk feed volumes.
To assess and compare the effects of a faster (30 ml/kg/day) and a slower (18 ml/kg/day) increase in milk feed volumes on survival of very preterm (<32 weeks) or VLBW (<1,500 g) infants without moderate or severe disability at 24 months of age corrected for prematurity.
To assess and compare the effects of a faster (30 ml/kg/day) and a slower (18 ml/kg/day) increase in milk feed volumes in very preterm (<32 weeks) or VLBW (<1,500 g) infants with respect to:
- incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection from trial entry until discharged home
- incidence of NEC (Bell stage 2 or 3) from trial entry until discharged home
- time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days)
- growth (weight and head circumference) when discharged home
- duration of parenteral feeding before discharged home
- length of time in intensive care
- length of hospital stay
- diagnosis of cerebral palsy by a doctor or other health professional (parent reported)
- REC Reference:
- Clinical Trials Unit:
- National Perinatal Epidemiology Unit CTU
- University of Oxford
- NIHR Health Technology Assessment (HTA) Programme
- Recruitment Target:
- 2,800 (recruitment total 2,804)
- Duration of Study:
- September 2013 - January 2019
If you would like to contact the trial team, please email email@example.com.