Initiation of complementary feeding before four months of age for prevention of postnatal growth restriction in preterm infants

To evaluate the effect and safety of initiation of complementary feeding (defined as semi-solid, soft or solid foods other than breast or animal milk and infant/follow-on formula) to preterm infants (less than 37 weeks postmenstrual age (PMA) at birth) at or before four months compared to anytime after four months of age, in two ways:

  1. initiating complementary feeding at or before four months (17 weeks) of corrected age compared to initiating complementary feeding anytime after four months (17 weeks) of corrected age;
  2. initiating complementary feeding at or before four months (17 weeks) of postnatal age compared to initiating complementary feeding anytime after four months (17 weeks) of postnatal age.

We will perform a subgroup analysis by foetal growth category (small for gestational age defined as birth weight less than 10th centile for gestational age, versus appropriate for gestational age defined as birth weight more than or equal to 10th centile for gestational age), type of feeding (exclusively or predominantly breast fed versus top fed with formula or animal milk or mixed fed prior to initiation of complementary foods), gestational age groups (less than 28 weeks PMA at birth versus 28 to 31 weeks PMA at birth versus 32 to 36 weeks PMA at birth), and by two specific time points at initiation of food, i.e., four months versus six months of age, as these are the two most debated time points for initiation of complementary feeding.

This is a protocol.

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