Sepsis Clinical Trial
— CHAINOfficial title:
Building the Evidence Base for Appropriate Care of the Sick, Undernourished Child in Limited Resource Settings
Verified date | May 2020 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The CHAIN Network aims to identify modifiable biomedical and social factors driving the
greatly increased risk of mortality among young undernourished children admitted to hospital
with acute illness, as inpatients and after discharge. The study will inform priorities,
risks and targeting for multi-faceted interventional trials.
CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological
samples. Study sites are located in Africa and South Asia. Children will be recruited at
admission to hospital, stratified by nutritional status. Exposures will be assessed at
admission, during hospitalisation, at discharge, and at two time points after discharge. The
main outcomes of interest are mortality, re-admission to hospital and failure of nutritional
recovery up to 180 days after discharge. To determine community health norms, an additional
sample of children living in the same communities will be enrolled and assessed at one time
point only.
Status | Active, not recruiting |
Enrollment | 4335 |
Est. completion date | October 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 23 Months |
Eligibility |
Inclusion criteria (hospitalized participants): - Children 2 months-23 months. - Admitted to hospital. - Planning to remain within the hospital catchment area and willing to come for specified visits during the 6 month follow up period. - Parent or guardian consents on child's behalf. Inclusion criteria (community participants): - Aged 2 to 23 months - Living in the same community as the acutely ill children recruited. - Not having an acute illness requiring hospital admission - Absence of known, but untreated HIV or TB - Not admitted to hospital within the last 14 days - Not previously included in the study - Parent or guardian consents on child's behalf. Exclusion Criteria (all participants): - Requiring immediate resuscitation at admission to hospital* - Unable to tolerate oral feeds while in his/her usual state of health - Underlying terminal illness that in the opinion of the treating physician is likely to lead to death within 6 months (e.g., cancer, congenital heart disease) - Diagnosed with a condition that in the opinion of the treating physician is likely to require surgery within 6 months - Diagnosed chromosomal abnormality (syndromically or genetically diagnosed abnormality) - Primary reason for admission is poisoning, trauma or a surgical condition - Previously enrolled in this study - Sibling currently or previously enrolled in this study (* children requiring resuscitation will be defined as those with on-going cardiac or pulmonary arrest or judged to be peri-arrest by the attending physician) |
Country | Name | City | State |
---|---|---|---|
Bangladesh | ICDDR,B Dhaka Hospital | Dhaka | |
Bangladesh | Matlab Hospital | Dhaka | Chittagong |
Kenya | Kilifi County Hospital | Kilifi | |
Kenya | Migori County Hospital | Migori | |
Kenya | Mbagathi District Hospital | Nairobi | |
Malawi | Queen Elizabeth Central Hospital | Blantyre | |
Pakistan | Civil Hospital Karachi | Karachi | |
Uganda | Mulago Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Aga Khan University, International Centre for Diarrhoeal Disease Research, Bangladesh, KEMRI-Wellcome Trust Collaborative Research Program, Kenya Medical Research Institute, Makerere University, Oregon Health and Science University, The Hospital for Sick Children, University of Amsterdam, University of Malawi, University of Washington |
Bangladesh, Kenya, Malawi, Pakistan, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Assessed using clinical and civil records and verbal autopsy | Up to 30 days after admission to hospital | |
Primary | Mortality | Assessed using clinical and civil records and verbal autopsy | Up to 180 days after discharge from hospital | |
Secondary | Rehospitalization | Number of participants, assessed from direct observation or clinical records | Up to 180 days after discharge from hospital | |
Secondary | Change in weight-for-height z-score | Post-discharge growth | Up to 180 days after discharge from hospital | |
Secondary | Change in length-for-age z-score | Post-discharge growth | Up to 180 days after discharge from hospital | |
Secondary | Change in mid-upper arm circumference | Post-discharge growth | Up to 180 days after discharge from hospital |
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