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Clinical Trials/CTRI/2019/05/019197
CTRI/2019/05/019197
Completed
Phase 3

Phase III, multicentre, randomized, double-blind, placebo-controlled study to evaluate efficacy of probiotic supplementation for prevention of neonatal sepsis in 0-2 months old low birth weight infants in India

Indian Council of Medical Research Hqrs0 sites6,144 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Indian Council of Medical Research Hqrs
Enrollment
6144
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Indian Council of Medical Research Hqrs

Eligibility Criteria

Inclusion Criteria

  • •1\. Birth weight: \=1500 g to \=2500 g
  • •2\. Age of the new\-born Day 3\-7 on recruitment i.e. not later than 7th day
  • •3\. Stable clinical condition as assessed by physician and accepting feeds orally (where stable is defined as, does not require intravenous fluids and vasopressor medication to maintain circulation and accepts oral feeding or breastfeeding).
  • •4\. The mother (with the new\-born) is planning to stay in study area for a period of at least two months

Exclusion Criteria

  • •1\. New born with extreme prematurity i.e. \= 34 weeks
  • •2\. New born with illness requiring prolonged hospitalisation and interference with oral feeding
  • •3\. Presence of a gross congenital malformation incompatible with life
  • •4\. Parent or Legally authorized representative (LAR) not providing written consent

Outcomes

Primary Outcomes

Not specified

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