Low Birth Weight Follow-up
Sponsor
Bandim Health Project (Other)
Overall Status
Completed
CT.gov ID
NCT03020147
Collaborator
(none)
1,258
1
47
26.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1258 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Follow-up of Low Birth Weight Cohort of 2008-2013
Actual Study Start Date
:
Feb 15, 2017
Actual Primary Completion Date
:
Dec 15, 2017
Actual Study Completion Date
:
Jan 15, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bandim Health Project | Bissau | Bissau Codex | Guinea-Bissau | 1004 |
Sponsors and Collaborators
- Bandim Health Project
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT03020147
Other Study ID Numbers:
- BandimHP
First Posted:
Jan 13, 2017
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021