SIFT - Speed of Increasing milk Feeds Trial
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]
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