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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926390
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rania Ismail, Ain Shams University

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE September 15, 2018
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
  • Neonatal mortality [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Number of deaths in the study group
  • Duration of hospital stay [ Time Frame: From time of randomization to discharge from nicu or death whichever comes first ]
    Duration of hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
Official Title  ICMJE Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Late Onset Neonatal Sepsis
  • Necrotizing Enterocolitis of Newborn
  • Feeding; Difficult, Newborn
Intervention  ICMJE Dietary Supplement: Bovine colostrum
bovine colostrum for first 2 weeks
Study Arms  ICMJE
  • No Intervention: Non bovine colostrun
    Preterm received preterm formula
  • Active Comparator: Bovine colostrum group
    Preterm received bovine colostrum as trophic feeding
    Intervention: Dietary Supplement: Bovine colostrum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2020)
80
Original Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
100
Actual Study Completion Date  ICMJE September 15, 2019
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926390
Other Study ID Numbers  ICMJE FMASU 50 / 2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: research protocol
Responsible Party Rania Ismail, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hisham Awad professor of pediatrics Ain Shams university
PRS Account Ain Shams University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP