Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates

NCT ID: NCT04886674

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-07-01

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

bovine colostrum

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

bovine colostrum

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

placebo

Eligibility Criteria

Inclusion Criteria

• Babies with birth weight ≤ 1500 g

Exclusion Criteria

• 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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Kamal Ali Abd El Hameed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mohamed kamal, M.B.B.Ch

Role: CONTACT

kemo6555@gmail.com

01027507508

mohammed gamil, assistant professor

Role: CONTACT

01024741834

References

Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.

Reference Type: BACKGROUND

PMID: 18547133 (View on PubMed)

Grave 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.

Reference Type: BACKGROUND

PMID: 17667844 (View on PubMed)

Hoy 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.

Reference Type: BACKGROUND

PMID: 11101593 (View on PubMed)

Peter 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.

Reference Type: BACKGROUND

PMID: 9950312 (View on PubMed)

Hoy 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.

Reference Type: BACKGROUND

PMID: 2122814 (View on PubMed)

Other Identifiers

Bovine Colostrum in NEC

Identifier Type: -

Identifier Source: org_study_id