Childhood Acute Illness and Nutrition Network (CHAIN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03208725 |
Recruitment Status :
Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : May 20, 2020
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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.
Condition or disease |
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Malnutrition Pneumonia Diarrhea Sepsis Bacteremia HIV/AIDS TB Enteropathy Antibiotic Resistant Strain |

Study Type : | Observational |
Actual Enrollment : | 4335 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Building the Evidence Base for Appropriate Care of the Sick, Undernourished Child in Limited Resource Settings |
Actual Study Start Date : | November 30, 2016 |
Actual Primary Completion Date : | January 31, 2020 |
Estimated Study Completion Date : | October 31, 2020 |
Group/Cohort |
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Hospitalized children with severe wasting or kwashiorkor (SWK)
Children recruited at admission to hospital and followed up for 180 days post-discharge.
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Community reference participants (CP)
Children recruited from the community who are seen a single appointment in the community.
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Hospitalized children with moderate wasting (MW)
Children recruited at admission to hospital and followed up for 180 days post-discharge.
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Hospitalized children without wasting (NW)
Children recruited at admission to hospital and followed up for 180 days post-discharge.
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- Mortality [ Time Frame: Up to 30 days after admission to hospital ]Assessed using clinical and civil records and verbal autopsy
- Mortality [ Time Frame: Up to 180 days after discharge from hospital ]Assessed using clinical and civil records and verbal autopsy
- Rehospitalization [ Time Frame: Up to 180 days after discharge from hospital ]Number of participants, assessed from direct observation or clinical records
- Change in weight-for-height z-score [ Time Frame: Up to 180 days after discharge from hospital ]Post-discharge growth
- Change in length-for-age z-score [ Time Frame: Up to 180 days after discharge from hospital ]Post-discharge growth
- Change in mid-upper arm circumference [ Time Frame: Up to 180 days after discharge from hospital ]Post-discharge growth
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 2 Months to 23 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Hospital and post-discharge cohort: Children being admitted to hospital.
Community reference participants: Children living in the same communities as those recruited into the hospitalized cohort.
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208725
Bangladesh | |
Matlab Hospital | |
Dhaka, Chittagong, Bangladesh | |
ICDDR,B Dhaka Hospital | |
Dhaka, Bangladesh | |
Kenya | |
Kilifi County Hospital | |
Kilifi, Kenya | |
Migori County Hospital | |
Migori, Kenya | |
Mbagathi District Hospital | |
Nairobi, Kenya | |
Malawi | |
Queen Elizabeth Central Hospital | |
Blantyre, Malawi | |
Pakistan | |
Civil Hospital Karachi | |
Karachi, Pakistan | |
Uganda | |
Mulago Hospital | |
Kampala, Uganda |
Principal Investigator: | James A Berkley, MBBS, FRCPCH | University of Oxford | |
Principal Investigator: | Judd L Wilson, MD, MPH | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT03208725 |
Other Study ID Numbers: |
OPP1131320 |
First Posted: | July 5, 2017 Key Record Dates |
Last Update Posted: | May 20, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Malnutrition Hospitalization Acute Illness Pediatric Post-discharge mortality Mortality |
Cohort Nested case control Antimicrobial resistance Antibiotic Feeding Undernutrition |
Bacteremia Pneumonia Malnutrition Diarrhea Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms, Digestive |
Nutrition Disorders Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |