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

NCT07233382 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-12-05

No results posted yet for this study

Summary

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.

Conditions

  • NEC
  • NEC - Necrotizing Enterocolitis

Interventions

DRUG

Probiotic

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

DRUG

10% dextrose

This will receive 10% DW as placebo

Sponsors & Collaborators

  • Hayatabad Medical Complex

    lead OTHER_GOV

Principal Investigators

  • Romisa Romisa, MBBS, FCPS · Hyatabad Medical Complex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-05-30
Completion
2026-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233382 on ClinicalTrials.gov