Feeding IntolerancePreColosNCT02054091
Feeding Bovine Colostrum to Preterm Infants
A study testing Bovine colostrum in people with Feeding Intolerance and Extrauterine Growth Retardation, run by Per Torp Sangild at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Feeding Intolerance, Extrauterine Growth Retardation, Necrotizing Enterocolitis
- What is being tested?
- Bovine colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2014to Jan 2017
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
China2 sites
Foshan Women and Children's Hospital (FWCH)
Foshan, Guangdong, 528000
Shenzheng Baoan Maternity and Child Healthcare Hospital (SBMCH)
Shenzhen, Guangdong, 518133
Denmark2 sites
Rigshospitalet (RH)
Copenhagen, 2100
Hvidovre Hospital (HH)
Hvidovre, 2650
About this study
Official title: Bovine Colostrum as Nutrition for Preterm Infants in the First Days of Life: A Pilot Feasibility Study
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.
Read the detailed description
Preterm birth (<37 weeks gestation) occurs in 10% of all pregnancies worldwide and the optimal way to feed a newborn preterm infant, when breast-feeding is impossible, is not clear. Excessive enteral feeding predisposes to various complications and necrotizing enterocolitis (NEC) that occur in 7% of preterm infants born with less than 1500 g body weight. Early feeding with small volumes of milk is applied to promote GIT maturation and add some nutrients and energy. It is assumed that early feeding allows more rapid advancement to full enteral feeding (EN, e.g 120-160 ml/kg/d) and weaning from parenteral nutrition (PN). This is important to reduce PN-related complications (e.g. sepsis) and to better stimulate body and organ (e.g. gut, brain) development. However, it remains unclear what is the best milk diet when mother's own milk (MM) is not available. Infant formula (IF) and banked human donor milk (DM) are the most frequently used alternatives to MM. MM is superior to IF in promoting feeding tolerance, intestinal function, and NEC resistance in preterm infants. Feeding with DM is also believed to be beneficial, relative to IF, although this pasteurized milk obtained from mothers later in lactation may be less beneficial, relative to the first milk, colostrum. There are differences in the amount and composition between human colostrum and bovine colostrum (BC), but relative to mature human milk, BC contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins). Large amount of protein in BC provides higher enteral protein intake and may enable a reduction in the use of PN and central venous catheters, and hereby reduced risk of infection. Also this may lead to reduced weight loss and improved growth of the brain and the body. In addition, maturational and NEC-protective effects of BC have repeatedly been documented in preterm pigs when BC is used as the first diet after birth. The investigators therefore plan to investigate whether using BC as nutrition for preterm infants in the first weeks of life is safe, tolerable, and helps to provide nutrients and gut maturation , when MM is not in sufficient amounts or not available.
- Conditions
- Feeding Intolerance, Extrauterine Growth Retardation, Necrotizing Enterocolitis, Sepsis, Meningitis
- Being tested
- Bovine colostrum
- Keywords
- Preterm infants, Bovine colostrum, Feeding intolerance, Postnatal growth, Intestinal maturation, Necrotizing enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing, Sepsis, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine colostrumDietary supplement
Also called Cow's 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bovine colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first
Secondary outcomes (7)
Anthropometry data
Body weight, body length, and head circumference are measured as anthropometry data
Measured: 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
Measured: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first
Days on parenteral nutrition
Days on PN are the total number of days that a participant receiving any i.v. nutrients other than glucose.
Measured: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first
Time to full enteral feeding
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.
Measured: 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
Serious infections/NEC includes sepsis and meningitis, according the diagnostic criteria at each hospital, and Bell stage II or III NEC.
Measured: From birth until the recruited subject reaches postmenstrual age at 37 weeks or discharge home, whichever comes first
Plasma citrulline level
Citrulline concentration is measured in plasma as a biomarker for absorptive enterocyte mass and/or function
Measured: On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH
Lactase activity and intestinal permeability
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.
Measured: On day 7±1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies 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
- Single group for first 12 infants RCT for next 40 infants
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Torp Sangild
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Torp Sangild, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Per T. Sangild, PhD, Study director, +45 35 33 26 98
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054091
- Sponsor's protocol ID
- H-3-2013-136
- Acronym
- PreColos
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2014
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Colostrum as Nutrition for Preterm Infants in the First Days of Life: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT02054091
- Acronym / sponsor ID
- PreColos / H-3-2013-136
- Conditions
- Feeding Intolerance, Extrauterine Growth Retardation, Necrotizing Enterocolitis, Sepsis, Meningitis
- Keywords
- Preterm infants, Bovine colostrum, Feeding intolerance, Postnatal growth, Intestinal maturation, Necrotizing enterocolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Per Torp SangildUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
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.
Detailed description
Preterm birth (<37 weeks gestation) occurs in 10% of all pregnancies worldwide and the optimal way to feed a newborn preterm infant, when breast-feeding is impossible, is not clear. Excessive enteral feeding predisposes to various complications and necrotizing enterocolitis (NEC) that occur in 7% of preterm infants born with less than 1500 g body weight. Early feeding with small volumes of milk is applied to promote GIT maturation and add some nutrients and energy. It is assumed that early feeding allows more rapid advancement to full enteral feeding (EN, e.g 120-160 ml/kg/d) and weaning from parenteral nutrition (PN). This is important to reduce PN-related complications (e.g. sepsis) and to better stimulate body and organ (e.g. gut, brain) development. However, it remains unclear what is the best milk diet when mother's own milk (MM) is not available. Infant formula (IF) and banked human donor milk (DM) are the most frequently used alternatives to MM. MM is superior to IF in promoting feeding tolerance, intestinal function, and NEC resistance in preterm infants. Feeding with DM is also believed to be beneficial, relative to IF, although this pasteurized milk obtained from mothers later in lactation may be less beneficial, relative to the first milk, colostrum. There are differences in the amount and composition between human colostrum and bovine colostrum (BC), but relative to mature human milk, BC contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins). Large amount of protein in BC provides higher enteral protein intake and may enable a reduction in the use of PN and central venous catheters, and hereby reduced risk of infection. Also this may lead to reduced weight loss and improved growth of the brain and the body. In addition, maturational and NEC-protective effects of BC have repeatedly been documented in preterm pigs when BC is used as the first diet after birth. The investigators therefore plan to investigate whether using BC as nutrition for preterm infants in the first weeks of life is safe, tolerable, and helps to provide nutrients and gut maturation , when MM is not in sufficient amounts or not available.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single group for first 12 infants RCT for next 40 infants
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Bovine colostrumInfants are fed bovine colostrum supplemented to mother's own milk (if avaible) for max. 10 days at RH and 14 days at FWCH \& SBMCH. |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 colostrumAlso: Cow's colostrumThe 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. | Dietary supplement | Colostrum group |
Primary outcome
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.
7 secondary outcomes
Anthropometry data
Time frame: 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
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
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
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
Plasma citrulline level
Time frame: On day 7±1 at RH & HH and on day 7±1 and 14±1 at FWCH & SBMCH
Lactase activity and intestinal permeability
Time frame: On day 7±1
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 22 Jan 2019.
- The current clinical trial is a part of the NEOMUNE project.Link provided by the sponsor.
Related trials for Feeding Intolerance
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Enteral Feeding Intolerance
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
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Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
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.
Per T. Sangild, PhD study director
+45 35 33 26 98
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine colostrum in people with Feeding Intolerance and Extrauterine Growth Retardation, run by Per Torp Sangild at 4 sites in 2 countries.
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 3 inclusion and 6 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China, 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.