NECNCT04886674
Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates
An observational study of NEC, run by Assiut University.
Trial summary
Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants. Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay. Read more about this study
- Who is it for?
- Ages 1 day to 5 months
- Conditions the study is for
- NEC
- What is being tested?
- bovine colostrum
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2022
- Phase
- Observational
- 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 1 day to 5 months
- All sexes
- No healthy volunteers
- Child
Study population: The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.
Who may be able to join
- Babies with birth weight ≤ 1500 g
Who cannot join
- Babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug.
- Those with suspected/ proven gastrointestinal malformations.
- Preexisting sepsis (definite or suspect) or NEC at the time of enrollment.
- Those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).
Trial locations and contacts
No sites are listed yet.
mohammed gamil, assistant professor contact
About this study
Official title: Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: a Prospective Study at Neonatology Unit of Children's Hospital Assiut University
Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants.
Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.
Read the detailed description
Necrotizing enterocolitis (NEC) primarily occurs in premature and very low birth weight (VLBW) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (NICUs) .
Many researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of NEC and bacteria belonging to Enterobacteriaceae have often been linked to NEC .
Colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in NICUs, leading to colonization with pathogenic bacteria .
Commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors.
These components have substantial homology to their human counterparts . Bovine colostrums has been tried in the treatment of Escherichia coli and Shigella and Rotavirus diarrhea in children, Helicobacter pylori infection in children and E. coli intestinal infection in term and preterm neonates.
No major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies .
In an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various Enterobacteriaceae species known to be associated with NEC to human intestinal epithelial cells .
A randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis .
Till date, there are no studies in neonates on the use of bovine colostrum for the prevention of NEC.
- Conditions
- NEC
- Being tested
- bovine colostrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bovine colostrumDietary supplement
Also called placebo
The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.
| Study group | Role | What they receive |
|---|---|---|
| Remuverol | The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier. 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 will be definite NEC
Subjects who will be suspected to have NEC (based on clinical features) undergo an abdominal X-ray and stool occult blood assay.
Measured: baseline
Secondary outcomes (1)
Descriptive statistics will be used for describing baseline variables.Dichotomous outcomes will be compared by Chi square test with continuity correction or Fisher's Exact as applicable.
Numerical variables will be compared by Student's t-test or Mann Whitney U-test, depending on distribution.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
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 NECStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Ali Abd El Hameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886674
- Sponsor's protocol ID
- Bovine Colostrum in NEC
- Status last verified
- May 2021
- First submitted
- 22 Apr 2021
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.
PubMed 18547133Grave GD, Nelson SA, Walker WA, Moss RL, Dvorak B, Hamilton FA, Higgins R, Raju TN. New therapies and preventive approaches for necrotizing enterocolitis: report of a research planning workshop. Pediatr Res. 2007 Oct;62(4):510-4. doi: 10.1203/PDR.0b013e318142580a.
PubMed 17667844Hoy CM, Wood CM, Hawkey PM, Puntis JW. Duodenal microflora in very-low-birth-weight neonates and relation to necrotizing enterocolitis. J Clin Microbiol. 2000 Dec;38(12):4539-47. doi: 10.1128/JCM.38.12.4539-4547.2000.
PubMed 11101593Peter CS, Feuerhahn M, Bohnhorst B, Schlaud M, Ziesing S, von der Hardt H, Poets CF. Necrotising enterocolitis: is there a relationship to specific pathogens? Eur J Pediatr. 1999 Jan;158(1):67-70. doi: 10.1007/s004310051012.
PubMed 9950312Hoy C, Millar MR, MacKay P, Godwin PG, Langdale V, Levene MI. Quantitative changes in faecal microflora preceding necrotising enterocolitis in premature neonates. Arch Dis Child. 1990 Oct;65(10 Spec No):1057-9. doi: 10.1136/adc.65.10_spec_no.1057.
PubMed 2122814
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: a Prospective Study at Neonatology Unit of Children's Hospital Assiut University
- ClinicalTrials.gov ID
- NCT04886674
- Acronym / sponsor ID
- Bovine Colostrum in NEC
- Conditions
- NEC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 14 May 2021 (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.
Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants.
Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.
Detailed description
Necrotizing enterocolitis (NEC) primarily occurs in premature and very low birth weight (VLBW) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (NICUs) .
Many researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of NEC and bacteria belonging to Enterobacteriaceae have often been linked to NEC .
Colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in NICUs, leading to colonization with pathogenic bacteria .
Commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors.
These components have substantial homology to their human counterparts . Bovine colostrums has been tried in the treatment of Escherichia coli and Shigella and Rotavirus diarrhea in children, Helicobacter pylori infection in children and E. coli intestinal infection in term and preterm neonates.
No major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies .
In an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various Enterobacteriaceae species known to be associated with NEC to human intestinal epithelial cells .
A randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis .
Till date, there are no studies in neonates on the use of bovine colostrum for the prevention of NEC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remuverol | – | Dietary Supplement: bovine colostrumThe neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier. |
Who may qualify
- Ages
- 1 day to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.
Key inclusion criteria (1 listed)
- Babies with birth weight ≤ 1500 g
Key exclusion criteria (4 listed)
- Babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug.
- Those with suspected/ proven gastrointestinal malformations.
- Preexisting sepsis (definite or suspect) or NEC at the time of enrollment.
- Those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).
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: placeboThe neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier. | Dietary supplement | Remuverol |
Primary outcome
The primary outcome will be definite NEC
Time frame: baseline
Subjects who will be suspected to have NEC (based on clinical features) undergo an abdominal X-ray and stool occult blood assay.
1 secondary outcome
Descriptive statistics will be used for describing baseline variables.Dichotomous outcomes will be compared by Chi square test with continuity correction or Fisher's Exact as applicable.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Background: PubMed 18547133Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.
- Background: PubMed 17667844Grave GD, Nelson SA, Walker WA, Moss RL, Dvorak B, Hamilton FA, Higgins R, Raju TN. New therapies and preventive approaches for necrotizing enterocolitis: report of a research planning workshop. Pediatr Res. 2007 Oct;62(4):510-4. doi: 10.1203/PDR.0b013e318142580a.
- Background: PubMed 11101593Hoy CM, Wood CM, Hawkey PM, Puntis JW. Duodenal microflora in very-low-birth-weight neonates and relation to necrotizing enterocolitis. J Clin Microbiol. 2000 Dec;38(12):4539-47. doi: 10.1128/JCM.38.12.4539-4547.2000.
- Background: PubMed 9950312Peter CS, Feuerhahn M, Bohnhorst B, Schlaud M, Ziesing S, von der Hardt H, Poets CF. Necrotising enterocolitis: is there a relationship to specific pathogens? Eur J Pediatr. 1999 Jan;158(1):67-70. doi: 10.1007/s004310051012.
- Background: PubMed 2122814Hoy C, Millar MR, MacKay P, Godwin PG, Langdale V, Levene MI. Quantitative changes in faecal microflora preceding necrotising enterocolitis in premature neonates. Arch Dis Child. 1990 Oct;65(10 Spec No):1057-9. doi: 10.1136/adc.65.10_spec_no.1057.
Related trials for NEC
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
RecruitingPhase 2/3
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
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.
mohammed gamil, assistant professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of NEC, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed kamal, M.B.B.Ch (01027507508, kemo6555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be definite NEC (time frame: baseline). 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 NCT04886674, 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 14 May 2021.