Bovine Colostrum as a Human Milk Fortifier for Preterm Infants

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    136
  • sponsor
    Per Torp Sangild
Updated on 25 March 2021
sepsis
enteral nutrition

Summary

Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). A fast transition to full EN is important to improve gut maturation and reduce the high risk of late-onset sepsis (LOS), related to their immature immunity in gut and blood. Conversely, too fast increase of EN predisposes to feeding intolerance and necrotizing enterocolitis (NEC). Further, human milk feeding is not sufficient to support nutrient requirements for growth of very preterm infants. Thus, it remains a difficult task to optimize EN transition, achieve adequate nutrient intake and growth, and minimize NEC and LOS in the postnatal period of very preterm infants. Mothers own milk (MM) is considered the best source of EN for very preterm infants and pasteurized human donor milk (DM) is the second choice if MM is absent or not sufficient. The recommended protein intake is 4-4.5 g/kg/d for very low birth infants when the target is a postnatal growth similar to intrauterine growth rates. This amount of protein cannot be met by feeding only MM or DM. Thus, it is common practice to enrich human milk with human milk fortifiers (HMFs, based on ingredients used in infant formulas) to increase growth, bone mineralization and neurodevelopment, starting from 7-14 d after birth and 80-160 ml/kg feeding volume per day. Bovine colostrum (BC) is the first milk from cows after parturition and is rich in protein (80-150 g/L) and bioactive components. These components may improve gut maturation, NEC protection, and nutrient assimilation, even across species. Studies in preterm pigs show that feeding BC alone, or DM fortified with BC, improves growth, gut maturation, and NEC resistance during the first 1-2 weeks, relative to DM, or DM fortified with conventional HMFs. On this background, the investigators hypothesize that BC, used as a fortifier for MM or DM, can reduce feeding intolerance than conventional fortifiers.

Description

Objectives

  1. To test if fortification of human milk with BC reduces feeding intolerance compared with currently used HMF.
  2. To verify the safety and tolerability of BC fortification and to monitor the rates of growth, NEC and sepsis, as investigated in a parallel trial in Denmark
  3. To explore new markers of growth, maturation, clinical interventions, and health outcomes, using samples of blood, plasma or feces collected during the trial

Trial design This study is a dual-center, non-blinded, two-armed, randomized, controlled trial.

Participants Parents to eligible very preterm infants admitted to the Neonatal Intensive Care Units (NICU) at Nanshan People's Hospital (NAN) and Baoan Maternal and Children's Hospital in Shenzhen, China will be asked for participation.

Sample size 68 infants per group, 136 in total

Data type Clinical data and biological materials (feces, whole blood, and plasma)

A parallel trial on BC used as human milk fortifier is conducting in Denmark (NCT03537365)

Details
Condition growth aspects, Necrotizing enterocolitis, Feeding Intolerance, Late Onset Neonatal Sepsis, late-onset neonatal sepsis
Treatment Bovine colostrum, FM85
Clinical Study IdentifierNCT03822104
SponsorPer Torp Sangild
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Very preterm infants born between gestational age 26 + 0 and 30 + 6 weeks (from the first day of the mother's last menstrual period and/or based on fetal ultrasound)
DM is given at the unit when MM is absent (or insufficient in amount)
Infants judged by the attending physician to be in need of nutrient fortification, as added in the form of HMF to MM and/or DM
Signed parental consent

Exclusion Criteria

Major congenital anomalies and birth defects
Infants who have had gastrointestinal surgery prior to randomization
Infants who have received IF prior to randomization
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