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Prevention of neonatal sepsis in low birth weight infants

Phase 3
Completed
Registration Number
CTRI/2019/05/019197
Lead Sponsor
Indian Council of Medical Research Hqrs
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
6144
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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