Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05730452

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

Interventions

Risk-stratified discharge and post-discharge care

Study Details

Brief summary:

In Uganda, about 5% of children discharged after hospitalization for a serious infection will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work to develop and evaluate models and technology to predict, before discharge, an individual child's risk of recurrent illness, as well as to provide additional post-discharge support to at-risk children. This study seeks to evaluate the effect of a novel "Smart Discharges" approach on childhood mortality and health seeking behaviour.

Conditions

Sepsis

Study ID

NCT05730452

Start date

Jul 16, 2017

Status verified date

Feb, 2023

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children under five years of age
  • Admission with a proven or suspected infection
  • Provide written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Previous enrolment in the study
  • Outside of hospital catchment
  • Language barrier
  • Direct admission following birth without having been discharged

Study Design

Enrollment

11700 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Phase 1: Observational, children 0-59 months of age

Phase 1: Observational only

experimental: Phase 2: Interventional, children 0-59 months of age

Phase 2: Intervention

Interventions

Risk-stratified discharge and post-discharge care

Interventional intensity is based on predicted risk. Predicted risk based on previously developed prediction algorithms.

Low risk: receive discharge education and counselling only; Moderate risk: Discharge education and counselling + 1 post-discharge follow-up referral at day 7; High risk: Discharge education and counselling + 3 post-discharge follow-up referrals (D2, D7, D14); Very high risk: Discharge education and counselling + 3 post-discharge follow-up referrals (D2, D7, D14, D28)

Primary outcome measure

  • Post-discharge mortality [ Time Frame: From discharge until 6 months post-discharge ]

Central Contacts and Locations

Central contacts

Matthew O Wiens, PharmD, PhD

1-604-829-2562Matthew.Wiens@bcchr.ca

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 2X8

Contacts

Matthew O Wiens, PharmD, PhD

604.829.2562matthew.wiens@bcchr.ca

More Information

Sponsor

University of British Columbia

Last update posted

Feb 15, 2023

Last verified

Feb, 2023

Keywords

  • sepsis
  • pediatrics
  • critical care
  • patient discharges

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-02-15.