252
Participants
Start Date
December 4, 2017
Primary Completion Date
February 28, 2022
Study Completion Date
February 28, 2022
Bovine Colostrum (BC) / intervention group
"Infants randomized to the intervention group will receive a maximum of 2.8 g bovine colostrum (BC, Biofiber, Gesten, Denmark), as the HMF added to 100 ml of MM and/or DM, when EN has reached a dose of 100-140 ml/kg/d and blood urea nitrogen (BUN) levels are below 5 mmol/l.~The infants starts with 1 g (0.5 g protein) BC per 100 ml human milk on the first day, increased to 2 g (1.0 g protein) on day 3, and finally 2.8 g (1.4 g protein) on day 5, if the infants only receive DM.~The intervention begins if the infants meet the inclusions criteria and the intervention lasts until the infants reach post menstrual age (PMA) 34+6 weeks or are discharged home (including participating in an early discharge program), or are transferred to non-participating neonatal units, whichever comes first."
FM85 / control group
"Infants randomized to the control group will receive a maximum of 4 g PreNAN FM85 (Nestlé, Vevey, Switzerland) as HMF, added to 100 ml MM and/or DM, when EN has reached a dose of 100-140 ml/kg/d and BUN levels are below 5 mmol/l.~The infants starts with 1 g (0.35 g protein) FM85 per 100 ml human milk on the first day, which will be increased to 3 g (1.05 g protein) on day 3 and finally 4 g (1.4 g protein) on day 5, if the infants only receive DM.~FM85 is the standard HMF used in all participating hospitals in Denmark. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed."
Rigshospitalet (RH), Copenhagen
Hvidovre Hospital (HH), Hvidovre
Herlev Hospital, Herlev
North Zealand Hospital, Hillerød
Odense University Hospital, Odense
Kolding Hospital, Kolding
Aarhus University Hospital, Aarhus
Kolding Sygehus
OTHER
Herlev Hospital
OTHER
Hvidovre University Hospital
OTHER
Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Nordsjaellands Hospital
OTHER
Per Torp Sangild
OTHER