MedTrace Logo

SEPSIS Observational Cohort Study in Young Infants in Bangladesh

NCT04012190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2083

Last updated 2022-10-31

No results posted yet for this study

Summary

Globally, infectious diseases such as sepsis, meningitis and pneumonia are among the leading causes of neonatal deaths. A recent observational study in South Asia highlighted the contribution of both bacterial and viral infections to the burden of illness in infants \<60 days of age; however, there remains a need to quantify the risk of severe infection (SI) among newborns in a Bangladeshi population. In collaboration with researchers in Bangladesh, investigators aim to generate knowledge regarding the incidence and risk factors of SI, including the composition of the intestinal microbiome, in young infants (birth to 60 days of age) in Dhaka, Bangladesh. Data will support the design and implementation of future trials to test the efficacy of novel interventions for the prevention of SI in young infants, to promote optimal growth and development, and to determine effects on other health outcomes in early infancy.

Conditions

  • Severe Infection and Non-injury Death

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Child Health Research Foundation, Bangladesh

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Daniel Roth · The Hospital for Sick Children

Eligibility

Min Age
0 Days
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-10-22
Completion
2022-10-22

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04012190 on ClinicalTrials.gov