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To study the efficacy and safety of early (at birth) versus late (34 weeks gestation) BCG vaccination in preterm babies born between 31-33 weeks gestation

Immunogenicity and safety of early versus delayed BCG vaccination in moderately preterm infants (31-33 weeks)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004019
Enrollment
180
Registered
2013-09-24
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- Moderately preterm Appropriate for Gestational age babies(31-33 weeks)

Interventions

Intervention1: Early BCG vaccination: Babies born between 31-33 weeks of gestation will be given BCG vaccine at birth, as against the standard practice of vaccinating after completing 34 weeks gestati

Sponsors

University College of Medical Sciences and Guru Tegh Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study shall include preterm AGA babies 31-33 weeks residing <10 km of GTBH and can be contacted whenever required

Exclusion criteria

Exclusion criteria: Babies of mothers suffering from tuberculosis or receiving antitubercular drugs eclampsia chronic infection severe anaemia known cases HIV positive, Hepatitis B positive Babies having clinical evidence of intrauterine infection undergoing exchange transfusion receiving blood or blood products severe birth asphyxia critically ill babies septicaemia. (3) Babies with congenital anomalies and or clinical suspicion of chromosomal disease

Design outcomes

Primary

MeasureTime frame
Purified protein derivative conversion by Mantoux test (induration 5-9 mm) rate at monthsTimepoint: Purified protein derivative conversion by Mantoux test (induration 5-9 mm) rate at 6 months

Secondary

MeasureTime frame
a) Four-fold rise in interferon-gamma levels in serum from baseline levels. b) BCG take up as measured by proportion of infants with local reaction and maximum transverse diameter of BCG scar. c) Complications of BCG vaccine Timepoint: 6, 10 and 14weeks 6 months

Countries

India

Contacts

Public ContactDr MMA Faridi

University College of Medical Sciences and Guru Tegh Bahadur Hospital, Dilshad Garden, Delhi

meghasaroha@gmail.com9891962026

Outcome results

None listed

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