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

NCT ID: NCT03926390

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-09-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Non bovine colostrun

Preterm received preterm formula

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bovine colostrum group

Preterm received bovine colostrum as trophic feeding

Group Type: ACTIVE_COMPARATOR

Bovine colostrum

Intervention Type: DIETARY_SUPPLEMENT

bovine colostrum for first 2 weeks

Interventions

Bovine colostrum

bovine colostrum for first 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rania Ismail

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisham Awad

Role: PRINCIPAL_INVESTIGATOR

professor of pediatrics Ain Shams university

Locations

Medicin

Giza, Abasseya, Egypt

Countries

Egypt

Other Identifiers

FMASU 50 / 2017

Identifier Type: -

Identifier Source: org_study_id