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OpenTrials
Completed

NCT Number: NCT03020147

Low Birth Weight Follow-up

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandim Health Project

Bissau, Bissau Codex, 1004, Guinea-Bissau

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. mortality differences between group who received early BCG and late BCG

    Time frame: up to 8 years of age

  2. mortality by parental scar status

    Time frame: up to 8 years of age

Secondary outcomes

  1. hospitalization rate between early BCG and late BCG group

    Time frame: last two weeks

  2. consultation rate between early BCG and late BCG group

    Time frame: last two weeks

  3. medication use between early BCG and late BCG group

    Time frame: last two weeks

Other outcomes

  1. hospitalization based on parental scar status

    Time frame: last two weeks

  2. consultations based on parental scar status

    Time frame: last two weeks

  3. medication use based on parental scar status

    Time frame: last two weeks

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2021
First posted
Jan 13, 2017
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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