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NCT03020147 Clinical Trial

Low Birth Weight Follow-up

Low Birth Weight Clinical Trial

Official title:
Follow-up of Low Birth Weight Cohort of 2008-2013

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03020147
Other study ID # BandimHP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2017
Est. completion date January 15, 2021

Study information
Verified date April 2021
Source Bandim Health Project
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1258
Est. completion date January 15, 2021
Est. primary completion date December 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Guinea-Bissau Bandim Health Project Bissau Bissau Codex

Sponsors (1)
Lead Sponsor Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

References & Publications (2)

Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sørensen 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. — View Citation

Biering-Sørensen 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-Guérin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other hospitalization based on parental scar status last two weeks
Other consultations based on parental scar status last two weeks
Other medication use based on parental scar status last two weeks
Primary mortality differences between group who received early BCG and late BCG up to 8 years of age
Primary mortality by parental scar status up to 8 years of age
Secondary hospitalization rate between early BCG and late BCG group last two weeks
Secondary consultation rate between early BCG and late BCG group last two weeks
Secondary medication use between early BCG and late BCG group last two weeks
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