Feeding Bovine Colostrum to Preterm Infants (PreColos)
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ClinicalTrials.gov Identifier: NCT02054091 |
Recruitment Status :
Completed
First Posted : February 4, 2014
Last Update Posted : January 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Feeding Intolerance Extrauterine Growth Retardation Necrotizing Enterocolitis Sepsis Meningitis | Dietary Supplement: Bovine colostrum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single group for first 12 infants RCT for next 40 infants |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Bovine Colostrum as Nutrition for Preterm Infants in the First Days of Life: A Pilot Feasibility Study |
Actual Study Start Date : | February 2014 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
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No Intervention: Control group
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).
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Experimental: Colostrum group
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.
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Dietary Supplement: Bovine colostrum
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.
Other Name: Cow's colostrum |
- The primary outcome is the tolerability of bovine colostrum feeding [ Time Frame: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]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.
- Anthropometry data [ Time Frame: Weekly measured from birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]Body weight, body length, and head circumference are measured as anthropometry data
- Days to regain birth weight [ Time Frame: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]
- Days on parenteral nutrition [ Time Frame: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]Days on PN are the total number of days that a participant receiving any i.v. nutrients other than glucose.
- Time to full enteral feeding [ Time Frame: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]Full enteral feeding is defined as participants receiving 160ml/kg/d at copenhagen site, or more than 120 ml/kg/d at Chinese sites for a consecutive period of 72 hours.
- Combined incidence of serious infections and NEC [ Time Frame: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first ]Serious infections/NEC includes sepsis and meningitis, according the diagnostic criteria at each hospital, and Bell stage II or III NEC.
- Plasma citrulline level [ Time Frame: On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH ]Citrulline concentration is measured in plasma as a biomarker for absorptive enterocyte mass and/or function
- Lactase activity and intestinal permeability [ Time Frame: On day 7±1 ]Lactase activity and intestinal permeability is measured non-invasively by measuring the urinary ratio of lactulose/lactose, and lactulose/mannitol after the three sugars are administered.
- Routine blood tests [ Time Frame: On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH ]Routine blood tests include blood gas analysis, liver enzymes, BUN, creatinine, Na, K, and phosphate.
- Plasma amino acid composition [ Time Frame: On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH ]Plasma amino acids will be analyzed at each hospital to investigate whether BC feeding provides a normal range of plasma amino acid pattern.
- Plasma bovine IgG level [ Time Frame: On day 7±1 at RH for phase A and B ]The concentration of intact bovine IgG will be measured in the plasma samples from the participants who receive BC supplementation, in order to investigate how much intact bovine IgG is absorbed from the intestine and circulating in the blood. This will only be measured in the participants at RH due to practical reasons.
- Fecal bovine IgG [ Time Frame: On day 7±1 at RH & HH and day 7±1 and 14±1 days ]The concentration of intact bovine IgG will be measured in the fecal samples from participants who receive BC supplementation, in order to investigate whether bovine IgG can survive digestion.
- Fecal short chain fatty acids (SCFAs) [ Time Frame: On day 7±1 at RH & HH and day 7±1 and 14±1 days ]Fecal SCFAs will be measured as an indicator of bacterial fermentation of the unabsorbed nutrients in the colon.
- Fecal microbiota composition [ Time Frame: On day 7±1 at RH & HH and day 7±1 and 14±1 days ]Microbiota composition in fecal samples will be determined using non-culture-based techniques

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Ages Eligible for Study: | up to 1 Day (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054091
China, Guangdong | |
Foshan Women and Children's Hospital (FWCH) | |
Foshan, Guangdong, China, 528000 | |
Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH) | |
Shenzhen, Guangdong, China, 518133 | |
Denmark | |
Rigshospitalet (RH) | |
Copenhagen, Denmark, 2100 | |
Hvidovre Hospital (HH) | |
Hvidovre, Denmark, 2650 |
Study Director: | Per T. Sangild, PhD | +45 35 33 26 98 |
Responsible Party: | Per Torp Sangild, Professor, Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT02054091 |
Other Study ID Numbers: |
H-3-2013-136 |
First Posted: | February 4, 2014 Key Record Dates |
Last Update Posted: | January 22, 2019 |
Last Verified: | January 2019 |
Preterm infants Bovine colostrum Feeding intolerance |
Postnatal growth Intestinal maturation Necrotizing enterocolitis |
Enterocolitis Enterocolitis, Necrotizing Meningitis Central Nervous System Diseases Nervous System Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |