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Clinical Trials/NCT07233382
NCT07233382Active, not recruitingNot Applicable

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

Hayatabad Medical Complex1 site in 1 country196 target enrollmentStarted: April 1, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
196
Locations
1
Primary Endpoint
Number of participants who develop NEC on probiotic vs placebo
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed Description

: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
— to 1 Day (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •• Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
  • •Infants with severe sepsis or gastrointestinal bleeding on presentation

Arms & Interventions

Placebo

Placebo Comparator

This group will receive 10% DW

Intervention: 10% dextrose (Drug)

Probiotic group - Intervention

Active Comparator

This group will receive intervention

Intervention: Probiotic (Drug)

Outcomes

Primary Outcomes

Number of participants who develop NEC on probiotic vs placebo

Time Frame: 30 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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