Feeding Bovine Colostrum to Preterm Infants

NCT02054091 | Completed DMC

• 1 other identifier: H-3-2013-136
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 4

Brief Summary

Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered as the best for the digestive system followed by donor milk. Preterm infant formula is related to more feeding problems and other gut complications in these babies, such as necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many other situations to promote health. The investigators plan to give bovine colostrum to preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6 weeks of gestational age, in order to promote feeding and intestinal health in these babies. This current study is a feasibility pilot study and the investigators hypothesized that supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14 days of life in preterm infants.

Conditions

Feeding Intolerance; Extrauterine Growth Retardation; Necrotizing Enterocolitis; Sepsis; Meningitis

Keywords

Preterm infants; Bovine colostrum; Feeding intolerance; Postnatal growth; Intestinal maturation; Necrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the tolerability of bovine colostrum feeding

  The main purpose of this feasibility pilot study is to investigate whether preterm infants can tolerate bovine colostrum as their first nutrition supplemented to mother's own milk (if available). Presence of feeding intolerance is defined as at any time when feeding is withheld by the neonatologists from day 1-7 and from day 8-14.

  From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

Secondary Outcomes (7)

• Anthropometry data

  Weekly measured from birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

• Days to regain birth weight

  From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

• Days on parenteral nutrition

  From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

• Time to full enteral feeding

  From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

• Combined incidence of serious infections and NEC

  From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first

Other Outcomes (6)

• Routine blood tests

  On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH

• Plasma amino acid composition

  On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH

• Plasma bovine IgG level

  On day 7±1 at RH for phase A and B

Study Arms (2)

Control group

NO INTERVENTION

Infants are fed according to the standard feeding practices at each hospital. At FWCH \& SBMCH babies are fed infant formula supplemented to mother's own milk (if avaible), and at RH, babies are fed donor milk supplemented to Mother'w own milk (if avaible).

Colostrum group

EXPERIMENTAL

Infants are fed bovine colostrum supplemented to mother's own milk (if avaible) for max. 10 days at RH and 14 days at FWCH \& SBMCH.

Dietary Supplement: Bovine colostrum

Interventions

Bovine colostrum DIETARY_SUPPLEMENT

The BC powder to be used in this study is donated from a Danish company, Biofiber Damino. The raw colostrum used for production is collected within 1-2 milking from healthy Danish dairy cows (Danish Holstein). Antibiotic residues are screened upon collection and those tested positive are not used for production. Intact colostrum is pasteurized, low temperature spray-dried, and sterilized by γ-irradiation.

Also known as: Cow's colostrum

Colostrum group

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• FWCH \& SBMCH: Preterm infants with birth weights between 1000 and 1800 g, delivered at FWCH \& SBMCH, or transferred from other hospitals within 24 h of birth and without any enteral feeding.
• RH \& HH: Preterm infants less than 24 hours of age, between 27+0 and 32+6 weeks of gestation, delivered at RH \&HH , or transferred from other hospitals within the first 24 h after birth.
• Signed parental consent

You may not qualify if:

• Major congenital anomalies or birth defects
• Congenital infection
• Perinatal asphyxia
• Gestational age at birth \< 28 weeks (FWCH \& SBMCH)
• Extremely SGA infant (weight SD score \< -3 SD)
• Need for mechanical ventilation or cardiovascular support before first BC feeding

Sponsors & Collaborators

• Per Torp Sangild: lead

Study Sites (4)

Foshan Women and Children's Hospital (FWCH)

Foshan, Guangdong, 528000, China

Location

Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)

Shenzhen, Guangdong, 518133, China

Location

Rigshospitalet (RH)

Copenhagen, 2100, Denmark

Location

Hvidovre Hospital (HH)

Hvidovre, 2650, Denmark

Location

Related Links

• The current clinical trial is a part of the NEOMUNE project.

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Sepsis; Meningitis

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Per T. Sangild, PhD

  +45 35 33 26 98

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single group for first 12 infants RCT for next 40 infants

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

DK (2); CN (2)