Clinical trial NCT03926390: Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
Official title: Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Late Onset Neonatal Sepsis
Necrotizing Enterocolitis of Newborn
Feeding; Difficult, Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Late Onset Sepsis in the three groups
timeFrame: From time of randomization to discharge from nicu or death whichever comes first
measure: The incidence of Necrotizing Enterocolitis in the three groups
timeFrame: From time of randomization to discharge from nicu or death whichever comes first
measure: The change of Active T regulatory cells In the three groups
timeFrame: Change from base line at randomization and after intervention by 1 week
Secondary outcomes:
measure: 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
timeFrame: From time of randomization to discharge from nicu or death whichever comes first
measure: Neonatal mortality
timeFrame: From time of randomization to discharge from nicu or death whichever comes first
measure: Duration of hospital stay
timeFrame: From time of randomization to discharge from nicu or death whichever comes first
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Medicin
state: Abasseya
Study officials:
affiliation: professor of pediatrics Ain Shams university
name: Hisham Awad
role: PRINCIPAL_INVESTIGATOR
References: