Low Birth Weight Follow-up

Completed

• Conditions: Non Specific Effects of Vaccine; Bacillus-Calmette-Guerin; Maternal Immunisation; Low Birth Weight

• Registration Number: NCT03020147
• Lead Sponsor: Bandim Health Project

Brief Summary

The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Study Start: 2017-02-15
• Primary Completion: 2017-12-15
• Study Completion: 2021-01-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1258

Inclusion Criteria

• Participation during the low birth weight BCG trial between 2008 and 2013.

Exclusion Criteria

• Not living in the Bandim Health Project's study area.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality differences between group who received early BCG and late BCG	up to 8 years of age
mortality by parental scar status	up to 8 years of age

Secondary Outcome Measures

Name	Time	Method
consultation rate between early BCG and late BCG group	last two weeks
hospitalization rate between early BCG and late BCG group	last two weeks
medication use between early BCG and late BCG group	last two weeks

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Bissau Codex, Guinea-Bissau