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

Ain Shams University

Status: Completed

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

Treatments: Dietary Supplement: Bovine colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT03926390

FMASU 50 / 2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 24 hours to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Non bovine colostrun

No Intervention group

Description:

Preterm received preterm formula

Bovine colostrum group

Active Comparator group

Description:

Preterm received bovine colostrum as trophic feeding

Treatment:

Dietary Supplement: Bovine colostrum