Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial

NCT03926390 | Completed DMC

• 1 other identifier: FMASU 50 / 2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.

Conditions

Late Onset Neonatal Sepsis; Necrotizing Enterocolitis of Newborn; Feeding; Difficult, Newborn

Outcome Measures

Primary Outcomes (3)

• Incidence of Late Onset Sepsis in the three groups

  Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system

  From time of randomization to discharge from nicu or death whichever comes first

• The incidence of Necrotizing Enterocolitis in the three groups

  Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging

  From time of randomization to discharge from nicu or death whichever comes first

• The change of Active T regulatory cells In the three groups

  Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3

  Change from base line at randomization and after intervention by 1 week

Secondary Outcomes (3)

• Feeding intolerance is defined as presence of at least 3 consecutive days of any of the following:emesis, gastric residuals, diarrhea, blood in stools or abnormally enlarged bowel loops

  From time of randomization to discharge from nicu or death whichever comes first

• Neonatal mortality

  From time of randomization to discharge from nicu or death whichever comes first

• Duration of hospital stay

  From time of randomization to discharge from nicu or death whichever comes first

Study Arms (2)

Non bovine colostrun

NO INTERVENTION

Preterm received preterm formula

Bovine colostrum group

ACTIVE COMPARATOR

Preterm received bovine colostrum as trophic feeding

Dietary Supplement: Bovine colostrum

Interventions

Bovine colostrum DIETARY_SUPPLEMENT

bovine colostrum for first 2 weeks

Bovine colostrum group

Eligibility Criteria

• Age: 24 Hours - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm Neonate having a gestational age equal or less than 34 weeks at birth, admitted in Ain-Shams University NICUs

You may not qualify if:

• Maternal risk factor of early onset sepsis, chorioamnionitis.
• Proved early onset sepsis.
• Life-threatening congenital abnormalities.
• Inborn error of metabolism.
• Chromosomal aberrations.
• Neonates with underlying gastrointestinal problems (such as GIT anomalies) that prevent enteral feeding.
• Perinatal asphyxia.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Medicin

Giza, Abasseya, 05000, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hisham Awad

  professor of pediatrics Ain Shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: April 24, 2019
• Study Start: September 15, 2018
• Primary Completion: June 15, 2019
• Study Completion: September 15, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)