GrowthFortiColosNCT03537365
Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants
A study testing Bovine Colostrum (BC) / intervention group in people with Growth and Necrotizing Enterocolitis, run by Per Torp Sangild at 7 sites in Denmark.
Trial summary
Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth and development. In the first weeks, they have difficulties tolerating enteral nutrition (EN) and are often given supplemental parenteral nutrition (PN). Read more about this study
- Who is it for?
- Ages 5 days to 3 weeks
- Conditions the study is for
- Growth, Necrotizing Enterocolitis, Late-Onset Sepsis
- What is being tested?
- Bovine Colostrum (BC) / intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 7 sitesDenmark
- Study dates
- 4 Dec 2017to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 days to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very preterm infants born between GA 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
- Infants admitted and staying at participating units at least until post menstrual age (PMA, gestational age + weeks and/or days since birth) 34+6 weeks, before being transferred to non-participating units, or going home participating in an "early discharge program". The infants can be transferred from one participating unit to another participating unit.
Who cannot join
- Major congenital anomalies and birth defects
- Infants who have had gastrointestinal surgery prior to randomization
- Infants who have received infant formula prior to randomization
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet (RH)
Copenhagen, 2100
Herlev Hospital
Herlev, 2730
North Zealand Hospital
Hillerød, 3400
Hvidovre Hospital (HH)
Hvidovre, 2650
Kolding Hospital
Kolding, 6000
Odense University Hospital
Odense, 5000
About this study
Official title: Bovine Colostrum to Fortify Human Milk for Preterm Infants A Randomized, Controlled Pilot Trial
Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth 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 VLBW 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 VLBW infants.
Mother´s own milk (MM) is considered the best source of EN for VLBW 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 VLBW 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, we hypothesize that BC, used as a fortifier for MM or DM, can induce similar growth and better NEC and LOS resistance, than conventional fortifiers. A pilot trial is required 1) to test the feasibility and initial safety of BC as a fortifier (e.g. similar growth rates and clinical variables as conventional fortification), 2) to calculate the sample size for a later, larger RCT with NEC +LOS as the primary outcome, and 3) record paraclinical outcomes associated with type of fortifier.
Read the detailed description
The main objectives of this multicentre, non-blinded, pilot, RCT are:
- To investigate the safety, tolerability and the preliminary effects of BC, used as an HMF for MM and DM in very preterm infants.
- To facilitate the determination of sample size for a later, larger RCT with NEC- and LOS-free survival as the primary outcome.
- To assess the feasibility of study procedures, incl. recruitment rates, parental consent, adherence, sample collection, and clinical routines.
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 Shenzen, China will be asked for participation.
Since this is a pilot trial, a conventional sample size calculation, using only one primary outcome, is not required. The aim is to include 200 infants (100 per group), which is expected to give sufficient strength to demonstrate effects on the chosen feasibility outcomes and secondary blood and stool variables (see protocol). Statistical analyses will be performed blindly on both intention-to-treat and per protocol basis. Continuous outcomes will be summarized as mean and standard deviation (e.g., body weight) or median and interquartile range (e.g. time to reach full enteral feeding). Binary outcomes (e.g. incidence of NEC) will be presented as counts and percentages. To test the preliminary effects of BC, clinical and para-clinical outcomes will be compared between the two groups. The estimates will be presented as relative risk and absolute risk difference, difference between means, or hazard ratio, depending on the type of outcome. The estimates will be presented with a 95% confidence interval. Further statistical analyses are described in the protocol.
- Being tested
- Bovine Colostrum (BC) / intervention group, FM85 / control group
- Keywords
- Human Milk Fortification, Bovine Colostrum, Very Preterm Infants, Enteral feeding, Human Milk, Neonatology, Colostrum
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Colostrum (BC) / intervention groupDietary supplement
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 100-140 ml/kg/d and blood urea nitrogen (BUN) levels are below 5 mmol/l.
The infants starts 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 begins if the infants meet the inclusions criteria and the intervention lasts until the infants reach post menstrual age (PMA) 34+6 weeks or are discharged home (including participating in an "early discharge program"), or are transferred to non-participating neonatal units, whichever comes first.
FM85 / control groupDietary supplement
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 100-140 ml/kg/d and BUN levels are below 5 mmol/l.
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.
FM85 is the standard HMF used in all participating hospitals in Denmark. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed.
| Study group | Role | What they receive |
|---|---|---|
| Bovine Colostrum / intervention group | Experimental | Preterm infants are supplemented with bovine colostrum (BC) as a fortifier to human milk. BC is the first milk from cows after parturition and is a rich source of protein (80-150 g/L) and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and growth factors. The product is supplied in a sterile, powdered form and consists of unmodified, intact BC. Receives: Dietary Supplement: Bovine Colostrum (BC) / intervention group |
| FM85 / control group | Active comparator | Preterm infants are supplemented with PreNAN FM85 as fortifier to human milk. PreNAN FM85 contains partially hydrolyzed protein and maltodextrin including vitamins and minerals. The product is supplied in a powdered form. Receives: Dietary Supplement: FM85 / control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight gain in grams from birth to discharge from hospital. Weight at different time points will be calculated into z-scores according to a reference. Delta z-scores will be used to evaluate growth and for comparison between groups.
Measured: From start of intervention to hospital discharge, or up to 14 weeks
Incidence of necrotizing entercolitis (NEC)
Number of infants in each group diagnosed with necrotizing enterocolitis (NEC) defined as Bell's stage II or above (Kliegman \& Walsh 1987).
Measured: From start of intervention to hospital discharge, or up to 14 weeks
Incidence of late-onset sepsis (LOS)
Number of infants in each group diagnosed with late-onset sepsis defined as clinical signs of infection >2 days after birth with antibiotic treatment for ≥5 days (or shorter than 5 days if the participant died) with or without one positive bacterial culture in blood or cerebral spinal fluid (CSF).
Measured: From start of intervention to hospital discharge, or up to 14 weeks
Secondary outcomes (7)
Feeding intolerence
Proportion of days with a feeding volume less than 50% of the total planned volume per day
Measured: From start of intervention to end of study period at post menstrual age 34+6 weeks, or up to 8 weeks
Time to reach full enteral feeding
Number of days to full enteral feeding is reached - defined as the time when >150 ml/kg/d is reached and parenteral nutrition has been discontinued
Measured: From birth to full enteral feeding, or up to 8 weeks
Days on parenteral nutrition
Number of days that the infant receives intravenous intakes of protein and/or lipid and/or glucose.
Measured: From birth to end of intervention, or up to 8 weeks
Length of hospital stay
Number of days in hospital, defined as days from birth until final discharge (including the days covered by an early discharge programme).
Measured: From birth until until final discharge, or up to 14 weeks
Blood urea nitrogen (BUN)
Blood urea nitrogen concentration is measured to evaluate the risk of excessive protein supply and immature kidney function
Measured: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Blood minerals
Blood levels of ionized phosphate, calcium and zink are measured to evaluate the risk of inadequate or excessive dietary mineral supply
Measured: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Blood haemoglobin
Determined to evaluate risk of anaemia and inadequate iron supply
Measured: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start4 Dec 2017
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, non-blinded, pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Torp Sangild
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, Herlev Hospital, Hvidovre University Hospital, Aarhus University Hospital, Odense University Hospital, Nordsjaellands Hospital
- Responsible party
- Sponsor-investigator, Per Torp Sangild, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gitte Zachariassen, MD., PhD, Principal investigator, Odense University HospitalPer Sangild, Prof, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537365
- Sponsor's protocol ID
- FortiColos (pilot RCT)
- Acronym
- FortiColos
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2018
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang L, Hui Y, Sangild PT, Kot WP, Aunsholt L, Zachariassen G, Jiang P-P, Nielsen DS. Gut microbiota development in very preterm infants following fortification of human milk. mSystems. 2025 Mar 18;10(3):e0091624. doi: 10.1128/msystems.00916-24. Epub 2025 Feb 21.
PubMed 39982063Ye Y, Yang L, Jiang PP, Sangild PT, Hui Y, Nielsen DS, Kappel SS, Aunsholt L, Zachariassen G, Bering SB, Khakimov B. Metabolomics reveals changes in levels of fecal branched chain amino acids and organic acids in very preterm infants fed human milk fortified with bovine colostrum. Clin Nutr. 2024 Dec;43(12):405-414. doi: 10.1016/j.clnu.2024.11.005. Epub 2024 Nov 6.
PubMed 39581179Simonsen MB, Kappel SS, Aunsholt L, Moller S, Sangild PT, Zachariassen G. Mineral supplementation for very preterm infants fed fortified human milk. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1389-1397. doi: 10.1002/jpn3.12190. Epub 2024 Apr 8.
PubMed 38587119Lewis AE, Kappel SS, Hussain S, Sangild PT, Zachariassen G, Aunsholt L. Trial-related blood sampling and red blood cell transfusions in preterm infants. Acta Paediatr. 2023 Dec;112(12):2486-2492. doi: 10.1111/apa.16948. Epub 2023 Aug 16.
PubMed 37565393Ahnfeldt AM, Hyldig N, Li Y, Kappel SS, Aunsholdt L, Sangild PT, Zachariassen G. FortiColos - a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial. Trials. 2019 May 22;20(1):279. doi: 10.1186/s13063-019-3367-7.
PubMed 31118098
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Colostrum to Fortify Human Milk for Preterm Infants A Randomized, Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03537365
- Acronym / sponsor ID
- FortiColos / FortiColos (pilot RCT)
- Keywords
- Human Milk Fortification, Bovine Colostrum, Very Preterm Infants, Enteral feeding, Human Milk, Neonatology, Colostrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Per Torp SangildUniversity, hospital or other
- Collaborators
- Kolding Sygehus, Herlev Hospital, Hvidovre University Hospital, Aarhus University Hospital, Odense University Hospital, Nordsjaellands Hospital
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth 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 VLBW 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 VLBW infants.
Mother´s own milk (MM) is considered the best source of EN for VLBW 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 VLBW 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, we hypothesize that BC, used as a fortifier for MM or DM, can induce similar growth and better NEC and LOS resistance, than conventional fortifiers. A pilot trial is required 1) to test the feasibility and initial safety of BC as a fortifier (e.g. similar growth rates and clinical variables as conventional fortification), 2) to calculate the sample size for a later, larger RCT with NEC +LOS as the primary outcome, and 3) record paraclinical outcomes associated with type of fortifier.
Detailed description
The main objectives of this multicentre, non-blinded, pilot, RCT are:
- To investigate the safety, tolerability and the preliminary effects of BC, used as an HMF for MM and DM in very preterm infants.
- To facilitate the determination of sample size for a later, larger RCT with NEC- and LOS-free survival as the primary outcome.
- To assess the feasibility of study procedures, incl. recruitment rates, parental consent, adherence, sample collection, and clinical routines.
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 Shenzen, China will be asked for participation.
Since this is a pilot trial, a conventional sample size calculation, using only one primary outcome, is not required. The aim is to include 200 infants (100 per group), which is expected to give sufficient strength to demonstrate effects on the chosen feasibility outcomes and secondary blood and stool variables (see protocol). Statistical analyses will be performed blindly on both intention-to-treat and per protocol basis. Continuous outcomes will be summarized as mean and standard deviation (e.g., body weight) or median and interquartile range (e.g. time to reach full enteral feeding). Binary outcomes (e.g. incidence of NEC) will be presented as counts and percentages. To test the preliminary effects of BC, clinical and para-clinical outcomes will be compared between the two groups. The estimates will be presented as relative risk and absolute risk difference, difference between means, or hazard ratio, depending on the type of outcome. The estimates will be presented with a 95% confidence interval. Further statistical analyses are described in the protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multicentre, non-blinded, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bovine Colostrum / intervention group | Experimental | Dietary Supplement: Bovine Colostrum (BC) / intervention groupPreterm infants are supplemented with bovine colostrum (BC) as a fortifier to human milk. BC is the first milk from cows after parturition and is a rich source of protein (80-150 g/L) and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and growth factors. The product is supplied in a sterile, powdered form and consists of unmodified, intact BC. |
| FM85 / control group | Active comparator | Dietary Supplement: FM85 / control groupPreterm infants are supplemented with PreNAN FM85 as fortifier to human milk. PreNAN FM85 contains partially hydrolyzed protein and maltodextrin including vitamins and minerals. The product is supplied in a powdered form. |
Who may qualify
- Ages
- 5 days to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Very preterm infants born between GA 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
- Infants admitted and staying at participating units at least until post menstrual age (PMA, gestational age + weeks and/or days since birth) 34+6 weeks, before being transferred to non-participating units, or going home participating in an "early discharge program". The infants can be transferred from one participating unit to another participating unit.
Key exclusion criteria (3 listed)
- Major congenital anomalies and birth defects
- Infants who have had gastrointestinal surgery prior to randomization
- Infants who have received infant formula prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Colostrum (BC) / intervention groupInfants 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 100-140 ml/kg/d and blood urea nitrogen (BUN) levels are below 5 mmol/l. The infants starts 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 begins if the infants meet the inclusions criteria and the intervention lasts until the infants reach post menstrual age (PMA) 34+6 weeks or are discharged home (including participating in an "early discharge program"), or are transferred to non-participating neonatal units, whichever comes first. | Dietary supplement | Bovine Colostrum / intervention group |
| FM85 / control groupInfants 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 100-140 ml/kg/d and BUN levels are below 5 mmol/l. 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. FM85 is the standard HMF used in all participating hospitals in Denmark. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed. | Dietary supplement | FM85 / control group |
Primary outcome
Body weight
Time frame: From start of intervention to hospital discharge, or up to 14 weeks
Weight gain in grams from birth to discharge from hospital. Weight at different time points will be calculated into z-scores according to a reference. Delta z-scores will be used to evaluate growth and for comparison between groups.
Incidence of necrotizing entercolitis (NEC)
Time frame: From start of intervention to hospital discharge, or up to 14 weeks
Number of infants in each group diagnosed with necrotizing enterocolitis (NEC) defined as Bell's stage II or above (Kliegman \& Walsh 1987).
Incidence of late-onset sepsis (LOS)
Time frame: From start of intervention to hospital discharge, or up to 14 weeks
Number of infants in each group diagnosed with late-onset sepsis defined as clinical signs of infection >2 days after birth with antibiotic treatment for ≥5 days (or shorter than 5 days if the participant died) with or without one positive bacterial culture in blood or cerebral spinal fluid (CSF).
7 secondary outcomes
Feeding intolerence
Time frame: From start of intervention to end of study period at post menstrual age 34+6 weeks, or up to 8 weeks
Time to reach full enteral feeding
Time frame: From birth to full enteral feeding, or up to 8 weeks
Days on parenteral nutrition
Time frame: From birth to end of intervention, or up to 8 weeks
Length of hospital stay
Time frame: From birth until until final discharge, or up to 14 weeks
Blood urea nitrogen (BUN)
Time frame: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Blood minerals
Time frame: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Blood haemoglobin
Time frame: Weekly from just before to end of intervention at postmenstrual age 34+6 weeks, or up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 39982063Yang L, Hui Y, Sangild PT, Kot WP, Aunsholt L, Zachariassen G, Jiang P-P, Nielsen DS. Gut microbiota development in very preterm infants following fortification of human milk. mSystems. 2025 Mar 18;10(3):e0091624. doi: 10.1128/msystems.00916-24. Epub 2025 Feb 21.
- Derived from this study: PubMed 39581179Ye Y, Yang L, Jiang PP, Sangild PT, Hui Y, Nielsen DS, Kappel SS, Aunsholt L, Zachariassen G, Bering SB, Khakimov B. Metabolomics reveals changes in levels of fecal branched chain amino acids and organic acids in very preterm infants fed human milk fortified with bovine colostrum. Clin Nutr. 2024 Dec;43(12):405-414. doi: 10.1016/j.clnu.2024.11.005. Epub 2024 Nov 6.
- Derived from this study: PubMed 38587119Simonsen MB, Kappel SS, Aunsholt L, Moller S, Sangild PT, Zachariassen G. Mineral supplementation for very preterm infants fed fortified human milk. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1389-1397. doi: 10.1002/jpn3.12190. Epub 2024 Apr 8.
- Derived from this study: PubMed 37565393Lewis AE, Kappel SS, Hussain S, Sangild PT, Zachariassen G, Aunsholt L. Trial-related blood sampling and red blood cell transfusions in preterm infants. Acta Paediatr. 2023 Dec;112(12):2486-2492. doi: 10.1111/apa.16948. Epub 2023 Aug 16.
- Derived from this study: PubMed 31118098Ahnfeldt AM, Hyldig N, Li Y, Kappel SS, Aunsholdt L, Sangild PT, Zachariassen G. FortiColos - a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial. Trials. 2019 May 22;20(1):279. doi: 10.1186/s13063-019-3367-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Zachariassen, MD., PhD principal investigator
Odense University Hospital
Per Sangild, Prof study chair
Copenhagen University Hospital, Rigshospitalet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine Colostrum (BC) / intervention group in people with Growth and Necrotizing Enterocolitis, run by Per Torp Sangild at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: From start of intervention to hospital discharge, or up to 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03537365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.