Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies

ConditionsNEC NEC - Necrotizing Enterocolitis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 1

SponsorHayatabad Medical Complex

About this trial

The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female preterm infants with a gestational age less than 35 weeks.

All indoor patients and outdoor patients who present within 24hrs of birth

Disqualifiers

• Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.

Infants with severe sepsis or gastrointestinal bleeding on presentation

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic
Drug
All preterm babies \<34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp. * Dose is 1 million international units (0.2ml or 5 drops) OD * Started as soon as feed is in initiated
10% dextrose
Drug
This will receive 10% DW as placebo

Treatment groups

196 Participants

are divided into 2 treatment groups

Group A: Probiotic group - InterventionActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants who develop NEC on probiotic vs placebo

Time frame

30 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hayatabad Medical Complex

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: