NCT04886674

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

April 22, 2021

Last Update Submit

May 12, 2021

Conditions

NEC

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    baseline

Study Arms (1)

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.

Dietary Supplement: bovine colostrum

Interventions

bovine colostrumDIETARY_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.

Also known as: placebo
Remuverol

Eligibility Criteria

Age1 Day - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Babies with birth weight ≤ 1500 g

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

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

    PMID: 18547133BACKGROUND

  • 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.

    PMID: 17667844BACKGROUND

  • 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.

    PMID: 11101593BACKGROUND

  • 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.

    PMID: 9950312BACKGROUND

  • 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.

    PMID: 2122814BACKGROUND

Central Study Contacts

mohamed kamal, M.B.B.Ch

CONTACT

01027507508kemo6555@gmail.com

mohammed gamil, assistant professor

CONTACT

01024741834

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 14, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 1, 2022

Last Updated

May 14, 2021

Record last verified: 2021-05