Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Childhood Acute Illness and Nutrition Network (CHAIN)

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
Sponsor:
Collaborators:
University of Washington
Kenya Medical Research Institute
KEMRI-Wellcome Trust Collaborative Research Program
Makerere University
Oregon Health and Science University
The Hospital for Sick Children
University of Amsterdam
University of Malawi
Aga Khan University
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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
Malnutrition Pneumonia Diarrhea Sepsis Bacteremia HIV/AIDS TB Enteropathy Antibiotic Resistant Strain

Show Show detailed description

Layout table for study information
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
Hospitalized children with severe wasting or kwashiorkor (SWK)
Children recruited at admission to hospital and followed up for 180 days post-discharge.
Community reference participants (CP)
Children recruited from the community who are seen a single appointment in the community.
Hospitalized children with moderate wasting (MW)
Children recruited at admission to hospital and followed up for 180 days post-discharge.
Hospitalized children without wasting (NW)
Children recruited at admission to hospital and followed up for 180 days post-discharge.



Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days after admission to hospital ]
    Assessed using clinical and civil records and verbal autopsy

  2. Mortality [ Time Frame: Up to 180 days after discharge from hospital ]
    Assessed using clinical and civil records and verbal autopsy


Secondary Outcome Measures :
  1. Rehospitalization [ Time Frame: Up to 180 days after discharge from hospital ]
    Number of participants, assessed from direct observation or clinical records

  2. Change in weight-for-height z-score [ Time Frame: Up to 180 days after discharge from hospital ]
    Post-discharge growth

  3. Change in length-for-age z-score [ Time Frame: Up to 180 days after discharge from hospital ]
    Post-discharge growth

  4. Change in mid-upper arm circumference [ Time Frame: Up to 180 days after discharge from hospital ]
    Post-discharge growth


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, rectal swabs, faeces, urine, peripheral blood mononuclear cells, bacterial isolates, PBMCs, TLR-stimulated whole blood, urine, breast milk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)


Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
University of Oxford
University of Washington
Kenya Medical Research Institute
KEMRI-Wellcome Trust Collaborative Research Program
Makerere University
Oregon Health and Science University
The Hospital for Sick Children
University of Amsterdam
University of Malawi
Aga Khan University
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Layout table for investigator information
Principal Investigator: James A Berkley, MBBS, FRCPCH University of Oxford
Principal Investigator: Judd L Wilson, MD, MPH University of Washington
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
Keywords provided by University of Oxford:
Malnutrition
Hospitalization
Acute Illness
Pediatric
Post-discharge mortality
Mortality
Cohort
Nested case control
Antimicrobial resistance
Antibiotic
Feeding
Undernutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
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