Low Birth Weight Follow-up

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03020147

Enrollment

1258

Registered

2017-01-13

Start date

2017-02-15

Completion date

2021-01-15

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
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

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

Other

Measure	Time frame
consultations based on parental scar status	last two weeks
medication use based on parental scar status	last two weeks
hospitalization based on parental scar status	last two weeks

Countries

Guinea-Bissau

Outcome results