Low Birth Weight Follow-up

April 22, 2021 updated by: Bandim Health Project

Follow-up of Low Birth Weight Cohort of 2008-2013

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
    • Bissau Codex
      • Bissau, Bissau Codex, Guinea-Bissau, 1004
        • Bandim Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children who participated in the low birth weight trial between 2008 and 2013.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality differences between group who received early BCG and late BCG
Time Frame: up to 8 years of age
up to 8 years of age
mortality by parental scar status
Time Frame: up to 8 years of age
up to 8 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
hospitalization rate between early BCG and late BCG group
Time Frame: last two weeks
last two weeks
consultation rate between early BCG and late BCG group
Time Frame: last two weeks
last two weeks
medication use between early BCG and late BCG group
Time Frame: last two weeks
last two weeks

Other Outcome Measures

Outcome Measure
Time Frame
hospitalization based on parental scar status
Time Frame: last two weeks
last two weeks
consultations based on parental scar status
Time Frame: last two weeks
last two weeks
medication use based on parental scar status
Time Frame: last two weeks
last two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BandimHP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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