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
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Rania Ismail, Ain Shams University

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	Intervention/treatment	Phase
Late Onset Neonatal Sepsis; Necrotizing Enterocolitis of Newborn; Feeding; Difficult, Newborn	Dietary Supplement: Bovine colostrum	Not Applicable

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 (Clinical Trial)
• 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 15, 2018
• Actual Primary Completion Date: June 15, 2019
• Actual Study Completion Date: September 15, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Non bovine colostrun; Preterm received preterm formula
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 Days (Child)
• 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

Locations

Egypt

Medicin

Giza, Abasseya, Egypt, 05000

Sponsors and Collaborators

Ain Shams University

Investigators

• Principal Investigator: Hisham Awad; professor of pediatrics Ain Shams university

More Information

• Responsible Party: Rania Ismail, Clinical professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03926390
• Other Study ID Numbers: FMASU 50 / 2017
• First Posted: April 24, 2019
• 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.: No

Additional relevant MeSH terms:

Sepsis; Neonatal Sepsis; Enterocolitis; Enterocolitis, Necrotizing; Infection; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infant, Newborn, Diseases