Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

February 28, 2022

Study Completion Date

February 28, 2022

Conditions
GrowthNecrotizing EnterocolitisLate-Onset SepsisFeeding Intolerance
Interventions
DIETARY_SUPPLEMENT

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."

DIETARY_SUPPLEMENT

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."

Trial Locations (7)

2100

Rigshospitalet (RH), Copenhagen

2650

Hvidovre Hospital (HH), Hvidovre

2730

Herlev Hospital, Herlev

3400

North Zealand Hospital, Hillerød

5000

Odense University Hospital, Odense

6000

Kolding Hospital, Kolding

8200

Aarhus University Hospital, Aarhus

All Listed Sponsors
collaborator

Kolding Sygehus

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Hvidovre University Hospital

OTHER

collaborator

Aarhus University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

Nordsjaellands Hospital

OTHER

lead

Per Torp Sangild

OTHER

NCT03537365 - Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants | Biotech Hunter | Biotech Hunter