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

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

• Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.
• Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.
• Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.

II. Thorough clinical assessment:

• Weight and Occiptofrontal circumference (twice weekly).
• Complete examination including cardiovascular, respiratory, abdominal and neurological examination.

III. Laboratory investigations:

• Complete blood picture, C-reactive protein on admission and repeated twice weekly
• Blood culture before starting treatment and with any suspected sepsis.
• 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.

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.