Bovine Colostrum for Preterm Newborns

Summary

Feeding intolerance is a common problem in very preterm infants due to their immature digestive system. This intolerance extends the time to full enteral feeding and thereby also prolongs the time on parenteral nutrition (PN). Prolonged time to full enteral feeding may predispose these infants to a higher risk of growth retardation, infections and organ dysfunctions (e.g. liver, brain). Mother's own milk (MM) is considered the optimal nutrition for preterm infants and is superior to infant formula (including preterm formula, PF) in stimulating gut maturation, feeding tolerance, resistance against necrotizing enterocolitis (NEC) and late-onset sepsis (LOS), and long-term neurodevelopmental outcomes. However, MM is often absent, or not available in sufficient amounts, during the first days or weeks after preterm delivery. Human donor milk (DM) is probably a better supplement to MM than PF, but DM is not available for all hospitals. To supplement insufficient MM during the early neonatal period in hospital settings with no access to donor milk, we suggest that bovine colostrum (BC) may be used instead of PF for very preterm infants during early life. BC, the first milk from cows after birth, is a rich source of protein and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to improve gut maturation and NEC/LOS resistance in a well-established piglet model of preterm infants. We suggest a randomized, controlled trial to investigate the effects of BC vs. PF, supplemented to MM during the first 2 weeks, on the time to full enteral feeding in very preterm infants.

Conditions

• Enteral Feeding Intolerance
• Necrotizing Enterocolitis
• Late-Onset Neonatal Sepsis

Interventions

DIETARY_SUPPLEMENT

Bovine Colostrum

Bovine colostrum (BC) is the first milk from cows after birth and we suggest that BC may be used to supplement MM, instead of infant formula or DM. BC is a rich source of protein (up to 150 g/L) and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as, IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to have beneficial effects in a well-established piglet model of preterm infants, using various feeding regimens, including a gradual regimen that would mimic enteral feeding for preterm infants without access to MM during the first week.

DIETARY_SUPPLEMENT

Preterm Formula

Preterm formula is a type of infant formula designed for preterm infants. It is used when mother's own milk is not available or not in sufficient amount as the enteral feeding for preterm infants in hospitals that do not have donor human milk.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Maternal and Child Health Hospital of Foshan

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Shenzhen Luohu Maternal and Child Health Hospital

  collaborator UNKNOWN

• University of Chinese Academy of Sciences - Shenzhen Hospital

  collaborator UNKNOWN

• Longgang District People's Hospital of Shenzhen

  collaborator OTHER

• Shenzhen Nanshan Maternity and Child Healthcare Hospital

  collaborator UNKNOWN

• Dongguan Women and Children's Hospital

  collaborator UNKNOWN

• Per Torp Sangild

  lead OTHER

Principal Investigators

• Per Sangild, PhD · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

2 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2020-10-23

Completion

2020-11-18

Countries

• China

Study Locations