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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03926390

Recruitment Status Completed

First Posted April 24, 2019

Last update posted June 23, 2020

Study Description

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.

  • Condition or Disease:Late Onset Neonatal Sepsis
    Necrotizing Enterocolitis of Newborn
    Feeding; Difficult, Newborn
  • Intervention/Treatment: Dietary Supplement: Bovine colostrum
  • Phase: N/A
Detailed Description

The study was interventional, double blinded and randomized trial ، performed on preterm neonates( <34 week) admitted on Ain ShamsUniversity (ASU) neonatal intensive care units (NICU) after considering exclusion criteria. The enrolled patients was subdivided into two groups; group A are infants with non bovine colstrum and group B with bovine colostrum All infants received the standard neonatal care and underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first. I. Data Collection: Careful history taking 1. Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection. 2. Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes. 3. Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection. II. Thorough clinical assessment: 1. Weight and Occiptofrontal circumference (twice weekly). 2. Complete examination including cardiovascular, respiratory, abdominal and neurological examination. III. Laboratory investigations: 1. Complete blood picture, C-reactive protein on admission and repeated twice weekly 2. Blood culture before starting treatment and with any suspected sepsis. 3. In first 24 hours and the end of second week : Collecting peripheral blood mononuclear cells to be analyzed for cellular parameters by flow cytometry (CD4 T cells, CD25 L, FOXP3). Three subsets of CD4+ T cells will be defined according to CD25 staining: CD25- , CD25 low, and CD25 high. Cells expressing CD25 high will be chosen and gated for the detection of FOXP3+ T cells. IV. Radiological investigations: Chest X-ray (It was done on admission and repeated when needed). Abdominal X-ray (when necrotizing enterocolitis is suspected). Abdominal ultrasound (when necrotizing enterocolitis is suspected). V. Follow-up and end-point of the study: All infant underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.NPO for more than 24 hours The following primary outcome data was recorded: - Clinical examination and laboratory investigations when clinically indicated for evidence of sepsis. - Clinical examination and radiological investigations when clinically indicated for evidence of NEC. A secondary outcome measure includes weight increment per kg per week, duration of hospitalization, mortality if any, monitoring adverse effects of treatment (if any); such as emesis, increased gastric residuals, increased abdominal girth, diarrhea, skin rash. Long term outcome includes necrotizing enterocolitis, and intracranial hemorrhage.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
  • Actual Study Start Date: September 2018
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Bovine colostrum group
Preterm received bovine colostrum as trophic feeding
Dietary Supplement: Bovine colostrum
bovine colostrum for first 2 weeks
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of Late Onset Sepsis in the three groups [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system
  • 2. The incidence of Necrotizing Enterocolitis in the three groups [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging
  • 3. The change of Active T regulatory cells In the three groups [ Time Frame: Change from base line at randomization and after intervention by 1 week ]
    Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3
  • Secondary Outcome Measures: 1. 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 [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Feeding intolerance
  • 2. Neonatal mortality [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Number of deaths in the study group
  • 3. Duration of hospital stay [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Duration of hospital stay
Eligibility Criteria
  • Ages Eligible for Study: up to 28 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- • 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.

Contacts and Locations
Contacts
Locations

Egypt, Abasseya
Medicin
Giza

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Hisham Awad professor of pediatrics Ain Shams university

More Information
  • Responsible Party: Ain Shams University
  • ClinicalTrials.gov Identifier: NCT03926390 History of Changes
  • Other Study ID Numbers: FMASU 50 / 2017
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: June 23, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: research protocol
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Sepsis
    Neonatal Sepsis
    Enterocolitis
    Enterocolitis, Necrotizing