Among low birth weight or preterm infants, does preterm versus term formula lead to fewer children with poor growth and fewer children with adverse neurodevelopment, without significant adverse effects? In separate comparisons, we will examine the effect of preterm vs term formula fed as sole diet, as supplement to human milk, or as either sole diet or supplement to human milk.
As the factors noted below may impact significantly on treatment effects, the following subgroup analyses will be performed:
- birth weight category (extremely LBW, less than or equal to 1000g) (as very small infants are at higher risk of adverse outcomes)
- gestational age (less than 28 weeks) (as very low gestation infants are at higher risk of adverse outcomes)
- male infants (outcomes for males are different from females)
- trials with longer duration of the intervention, i.e. trials continuing the intervention post-discharge from hospital (as preterm infants may not receive their recommended dietary intakes while still in hospital)
- in utero growth retardation (small and appropriate for gestational age infants may have different nutritional requirements. Studies indicating very low birth weight infants will have a higher percentage of small for gestational age infants than the normal populations.)
This is a protocol.