Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
Condition: Late Onset Neonatal Sepsis; Necrotizing Enterocolitis of Newborn; Feeding; Difficult, Newborn
MeSH terms: Sepsis; Neonatal Sepsis; Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional

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.
    

Intervention name(s): Bovine colostrum
Intervention type(s): Dietary Supplement
Intervention description(s): bovine colostrum for first 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention