Low Birth Weight Follow-up
Follow-up of Low Birth Weight Cohort of 2008-2013
1 other identifier
observational
1,258
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedApril 26, 2021
April 1, 2021
10 months
January 10, 2017
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
hospitalization rate between early BCG and late BCG group
last two weeks
consultation rate between early BCG and late BCG group
last two weeks
medication use between early BCG and late BCG group
last two weeks
Other Outcomes (3)
hospitalization based on parental scar status
last two weeks
consultations based on parental scar status
last two weeks
medication use based on parental scar status
last two weeks
Study Arms (2)
early BCG
Children received BCG soon after their birth between 2008 and 2013.
delayed BCG
Children received BCG when they are 2,5kg between 2008 and 2013.
Eligibility Criteria
Children who participated in the low birth weight trial between 2008 and 2013.
You may qualify if:
- Participation during the low birth weight BCG trial between 2008 and 2013.
You may not qualify if:
- Not living in the Bandim Health Project's study area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandim Health Project
Bissau, Bissau Codex, 1004, Guinea-Bissau
Related Publications (2)
Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
PMID: 21673035BACKGROUNDBiering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
PMID: 22189537BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 13, 2017
Study Start
February 15, 2017
Primary Completion
December 15, 2017
Study Completion
January 15, 2021
Last Updated
April 26, 2021
Record last verified: 2021-04