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Effect of BCG vaccine in decreasing mortality among babies with birth weight less than 2000g

BCG Green Signal Lab (originally derived from BCG Denmark) versus no BCG: effect on neonatal mortality among babies 2000g birth weight (BLOW Trial 2).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007676
Enrollment
1998
Registered
2017-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Low birth weight neonates

Interventions

Intervention1: BCG Green Signal (originally derived from BCG Denmark): These low birth weight babies ( 2000g birth weight) in Group A - will receive BCG Green Signal and OPV soon after admission to NI

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All babies weighing less than 2000 gram at the time of admission to NICU

Exclusion criteria

Exclusion criteria: 1) Babies less than 60 minutes of age; (2) Babies not likely to survive more than 24 hours; (3) babies older than 21 days of age; (4) babies with a major life-threatening malformation; (5) the mother or baby is known to have HIV, hepatitis B, herpes zoster or immuno¬deficiency; (6) the baby has already received BCG; or (7) the family refuses consent.

Design outcomes

Primary

MeasureTime frame
mortality up to 28 days of age Babies who are discharged (or who leave against medical advice) before 28 days of age will be followed-up at 29 days (or soon after) to determine whether they survived to 28 days and whether they have been given any vaccines. Timepoint: 0- 28 days

Secondary

MeasureTime frame
mortality up to 28 days of age in all babies, and time from randomisation to death in the first 28 days of life - in babies whose mother has a BCG scar and in all babies.Timepoint: 0- 28 days

Countries

India

Contacts

Public ContactDr Adhisivam

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH

drvishnubhat@yahoo.com9842351282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026