Work Package 4 (WP4)

WP4.1: COL supplement to MM for preterm infants for the first 1-2 weeks

Background: Early MM feeding of preterm infants is important, but MM is often insufficient due to delayed lactation after preterm birth. DM is generally accepted as the best supplement to MM, but may still be suboptimal, rather expensive and not available in many parts of the world. IF is considered inferior to both MM and DM to stimulate feeding tolerance, intestinal maturation, and NEC/infection resistance. COL appears safe when supplemented to MM for preterm infants during the first two weeks of life. Superiority of COL versus IF to stimulate feeding tolerance needs to be proven in a well-powered randomized controlled trial where DM is not an option. This is generally the case in China and the time to full feeding (TFF) is longer in South China versus Europe, according to our earlier observational studies.

Methods: VLBW preterm infants (n = 352) in 8 hospitals in Guangdong (population 100 mio.) and 1 hospital in Taiwan are fed COL, as a supplement to MM, when MM is not available or not sufficient, for up to 2 weeks before transition to full MM/IF feeding. Primary endpoint: TFF at 150 ml/kg/d. Secondary endpoints: NEC, sepsis, growth, feeding tolerance, gut microbiota, brain development, death.

Expected results: When MM is not available or not sufficient, we expect that supplemental COL during the first 2 weeks of life shortens the time to reach full enteral feeding at 150 ml/kg/d in VLBW infants, relative to supplemental preterm IF during the first 2 weeks.