Childhood Acute Illness and Nutrition Network

NCT03208725 | Unknown

• 1 other identifier: OPP1131320
• Study Type: observational
• Target: 4,335
• Locations: 5 countries
• Sites: 8

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.

Conditions

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

Keywords

Malnutrition; Hospitalization; Acute Illness; Pediatric; Post-discharge mortality; Mortality; Cohort; Nested case control; Antimicrobial resistance; Antibiotic; Feeding; Undernutrition

Outcome Measures

Primary Outcomes (2)

• Mortality

  Assessed using clinical and civil records and verbal autopsy

  Up to 30 days after admission to hospital

• Mortality

  Assessed using clinical and civil records and verbal autopsy

  Up to 180 days after discharge from hospital

Secondary Outcomes (4)

• Rehospitalization

  Up to 180 days after discharge from hospital

• Change in weight-for-height z-score

  Up to 180 days after discharge from hospital

• Change in length-for-age z-score

  Up to 180 days after discharge from hospital

• Change in mid-upper arm circumference

  Up to 180 days after discharge from hospital

Study Arms (4)

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.

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead
• University of Washington: collaborator
• Kenya Medical Research Institute: collaborator
• KEMRI-Wellcome Trust Collaborative Research Program: collaborator
• Makerere University: collaborator
• Oregon Health and Science University: collaborator
• The Hospital for Sick Children: collaborator
• University of Amsterdam: collaborator
• University of Malawi: collaborator
• Aga Khan University: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (8)

Matlab Hospital

Dhaka, Chittagong, Bangladesh

Location

ICDDR,B Dhaka Hospital

Dhaka, Bangladesh

Location

Kilifi County Hospital

Kilifi, Kenya

Location

Migori County Hospital

Migori, Kenya

Location

Mbagathi District Hospital

Nairobi, Kenya

Location

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Civil Hospital Karachi

Karachi, Pakistan

Location

Mulago Hospital

Kampala, Uganda

Location

Related Publications (3)

• Njunge JM, Tickell K, Diallo AH, Sayeem Bin Shahid ASM, Gazi MA, Saleem A, Kazi Z, Ali S, Tigoi C, Mupere E, Lancioni CL, Yoshioka E, Chisti MJ, Mburu M, Ngari M, Ngao N, Gichuki B, Omer E, Gumbi W, Singa B, Bandsma R, Ahmed T, Voskuijl W, Williams TN, Macharia A, Makale J, Mitchel A, Williams J, Gogain J, Janjic N, Mandal R, Wishart DS, Wu H, Xia L, Routledge M, Gong YY, Espinosa C, Aghaeepour N, Liu J, Houpt E, Lawley TD, Browne H, Shao Y, Rwigi D, Kariuki K, Kaburu T, Uhlig HH, Gartner L, Jones K, Koulman A, Walson J, Berkley J. The Childhood Acute Illness and Nutrition (CHAIN) network nested case-cohort study protocol: a multi-omics approach to understanding mortality among children in sub-Saharan Africa and South Asia. Gates Open Res. 2022 Nov 3;6:77. doi: 10.12688/gatesopenres.13635.2. eCollection 2022.

  PMID: 36415883 DERIVED

• Tickell KD, Denno DM, Saleem A, Ali A, Kazi Z, Singa BO, Otieno C, Mutinda C, Ochuodho V, Richardson BA, Asbjornsdottir KH, Hawes SE, Berkley JA, Walson JL. Enteric Permeability, Systemic Inflammation, and Post-Discharge Growth Among a Cohort of Hospitalized Children in Kenya and Pakistan. J Pediatr Gastroenterol Nutr. 2022 Dec 1;75(6):768-774. doi: 10.1097/MPG.0000000000003619. Epub 2022 Sep 20.

  PMID: 36123771 DERIVED

• Childhood Acute Illness and Nutrition Network. Childhood Acute Illness and Nutrition (CHAIN) Network: a protocol for a multi-site prospective cohort study to identify modifiable risk factors for mortality among acutely ill children in Africa and Asia. BMJ Open. 2019 May 5;9(5):e028454. doi: 10.1136/bmjopen-2018-028454.

  PMID: 31061058 DERIVED

Related Links

• The CHAIN Network
• Childhood Acute Illness and Nutrition (CHAIN) Network: a protocol for a multi-site prospective cohort study to identify modifiable risk factors for mortality among acutely ill children in Africa and Asia

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

MeSH Terms

Conditions

Malnutrition; Pneumonia; Diarrhea; Sepsis; Bacteremia; Acquired Immunodeficiency Syndrome; Intestinal Diseases

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Bacterial Infections; Bacterial Infections and Mycoses; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• James A Berkley, MBBS, FRCPCH

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Judd L Wilson, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: July 5, 2017
• Study Start: November 30, 2016
• Primary Completion: January 31, 2020
• Study Completion: October 31, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); KE (3); MA (1); BA (2); UG (1)