Bovine Colostrum as a Human Milk Fortifier for Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

May 1, 2019

Primary Completion Date

June 13, 2021

Study Completion Date

July 8, 2021

Conditions
Feeding IntoleranceNecrotizing EnterocolitisPostnatal GrowthLate-Onset Neonatal Sepsis
Interventions
DIETARY_SUPPLEMENT

Bovine Colostrum

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 80-100 ml/kg/d. The infants start 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 lasts until the infants reach postmenstrual age (PMA) 35+6 weeks or in no-need of fortification due to sufficient growth, whichever comes first.

DIETARY_SUPPLEMENT

FM85

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 80-100 ml/kg/d. 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. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed until discharge.

Trial Locations (2)

518133

Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH), Shenzhen

Unknown

Shenzhen Nanshan People's Hospital, Shenzhen

All Listed Sponsors
lead

Per Torp Sangild

OTHER

NCT03822104 - Bovine Colostrum as a Human Milk Fortifier for Preterm Infants | Biotech Hunter | Biotech Hunter