MedPath

a clinical study to analyse the effectiveness of administration of harmless bacteria in preventing infection of intestine in preterm babies

Phase 2
Completed
Conditions
Health Condition 1: null- prematurity , necrotising enterocolitis
Registration Number
CTRI/2012/09/003008
Lead Sponsor
lpnandhini
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
220
Inclusion Criteria

birth weight > 1000 grams

gestational age - 28 - 34 weeks

enterally fed

Exclusion Criteria

surgical conditions of gastrointestinal tract

severe birth asphyxia

major congenital malformations

chromosomal anomalies

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
incidence and severity of NECTimepoint: during period of hospital stay
Secondary Outcome Measures
NameTimeMethod
death due to NEC and sepsisTimepoint: during hospital stay
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