Low Birth Weight Follow-up

NCT ID: NCT03020147

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2021-01-15

Brief Summary

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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

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Conditions

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Non Specific Effects of Vaccine Bacillus-Calmette-Guerin Low Birth Weight Maternal Immunisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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early BCG

Children received BCG soon after their birth between 2008 and 2013.

No interventions assigned to this group

delayed BCG

Children received BCG when they are 2,5kg between 2008 and 2013.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bandim Health Project

Bissau, Bissau Codex, Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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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.

Reference Type BACKGROUND
PMID: 21673035 (View on PubMed)

Biering-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.

Reference Type BACKGROUND
PMID: 22189537 (View on PubMed)

Other Identifiers

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BandimHP

Identifier Type: -

Identifier Source: org_study_id

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