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Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Primary Purpose

Preterm

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

The bovine colostrum ( trade name : baby steps sachets, 300mg )

Placebo

About this trial

This is an interventional treatment trial for Preterm focused on measuring Premature infants, colostrum, ROP

Eligibility Criteria

1 Hour - 3 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life

Exclusion Criteria:

Exclusion criteria

Patients with any of the following will be excluded:

Obvious major congenital abnormalities.
Infants expected to be >72 hours of age at the time of randomization.
Parental consent lacking/refusal

Sites / Locations

Alexandria university, Elshattbi hospital
Marwa Mohamed Farag

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I: bovine colostrum group

group II : control group

Arm Description

Outcomes

Primary Outcome Measures

Fundus examination to detect retinopathy of prematurity

ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease

Secondary Outcome Measures

prematurity related complications

late onset sepsis IVH Necrotizing enterocolitis bronchopulmonary dysplasia

Assessment of weight

-Assessment of weight every other day.

-Assessment of Head circumference

measurement of Head circumference weekly.

-Assessment of length

-Assessment of length on admission and on discharge.

Full Information

NCT ID

NCT05438680

First Posted

June 13, 2022

Last Updated

October 11, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05438680

Brief Title

Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

Official Title

Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

June 20, 2022 (Actual)

Primary Completion Date

September 20, 2023 (Actual)

Study Completion Date

October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.

Detailed Description

This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital. The study will be carried out in 4 phases: First phase: Enrollment and selection phase. Second phase: Intervention phase ( enteral bovine colostrum administration) . Third phase: Evaluation phase. Fourth phase: collected data analysis and results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm

Keywords

Premature infants, colostrum, ROP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.

Masking

Participant

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I: bovine colostrum group

Arm Type

Active Comparator

Arm Title

group II : control group

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

The bovine colostrum ( trade name : baby steps sachets, 300mg )

Intervention Description

The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days. Enteral route, either through nasogastric tube or orally.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

distilled water with no bovine colostrum

Primary Outcome Measure Information:

Title

Fundus examination to detect retinopathy of prematurity

Description

ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease

Time Frame

28 days

Secondary Outcome Measure Information:

Title

prematurity related complications

Description

late onset sepsis IVH Necrotizing enterocolitis bronchopulmonary dysplasia

Time Frame

28 days

Title

Assessment of weight

Description

-Assessment of weight every other day.

Time Frame

28 days

Title

-Assessment of Head circumference

Description

measurement of Head circumference weekly.

Time Frame

28 days

Title

-Assessment of length

Description

-Assessment of length on admission and on discharge.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Hour

Maximum Age & Unit of Time

3 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life Exclusion Criteria: Exclusion criteria Patients with any of the following will be excluded: Obvious major congenital abnormalities. Infants expected to be >72 hours of age at the time of randomization. Parental consent lacking/refusal

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Alaaaldin Thabet, PhD

Organizational Affiliation

Faculty of medicine, Alexandria University, Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Islam Shereen Hamdy, PhD

Organizational Affiliation

Faculty of medicine, Alexandria University, Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eman Shabban Mohamed, MBBCh

Organizational Affiliation

Faculty of medicine, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marwa Mohamed Farag, PhD

Organizational Affiliation

Faculty of medicine, Alexandria University, Egypt

Official's Role

Study Chair

Facility Information:

Facility Name

Alexandria university, Elshattbi hospital

City

Alexandria

ZIP/Postal Code

0354

Country

Egypt

Facility Name

Marwa Mohamed Farag

City

Alexandria

ZIP/Postal Code

0356

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity

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