Phase 2: Interventional, children 0-59 months of age for Sepsis
Study Summary
This trial seeks to reduce childhood mortality in Uganda by predicting risk of recurrent illness and providing post-discharge support.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: From discharge until 6 months post-discharge
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Phase 1: Observational, children 0-59 months of age
1 of 2
Phase 2: Interventional, children 0-59 months of age
1 of 2
Active Control
Experimental Treatment
11700 Total Participants · 2 Treatment Groups
Primary Treatment: Phase 2: Interventional, children 0-59 months of age · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age No minimum age - 59 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Nemetchek B, English L, Kissoon N, Ansermino JM, Moschovis PP, Kabakyenga J, Fowler-Kerry S, Kumbakumba E, Wiens MO. Paediatric postdischarge mortality in developing countries: a systematic review. BMJ Open. 2018 Dec 28;8(12):e023445. doi: 10.1136/bmjopen-2018-023445.
- Wiens MO, Kissoon N, Kumbakumba E, Singer J, Moschovis PP, Ansermino JM, Ndamira A, Kiwanuka J, Larson CP. Selecting candidate predictor variables for the modelling of post-discharge mortality from sepsis: a protocol development project. Afr Health Sci. 2016 Mar;16(1):162-9. doi: 10.4314/ahs.v16i1.22.
- Nemetchek BR, Liang LD, Kissoon N, Ansermino JM, Kabakyenga J, Lavoie PM, Fowler-Kerry S, Wiens MO. Predictor variables for post-discharge mortality modelling in infants: a protocol development project. Afr Health Sci. 2018 Dec;18(4):1214-1225. doi: 10.4314/ahs.v18i4.43.
- Wiens MO, Kumbakumba E, Larson CP, Ansermino JM, Singer J, Kissoon N, Wong H, Ndamira A, Kabakyenga J, Kiwanuka J, Zhou G. Postdischarge mortality in children with acute infectious diseases: derivation of postdischarge mortality prediction models. BMJ Open. 2015 Nov 25;5(11):e009449. doi: 10.1136/bmjopen-2015-009449.
- English LL, Dunsmuir D, Kumbakumba E, Ansermino JM, Larson CP, Lester R, Barigye C, Ndamira A, Kabakyenga J, Wiens MO. The PAediatric Risk Assessment (PARA) Mobile App to Reduce Postdischarge Child Mortality: Design, Usability, and Feasibility for Health Care Workers in Uganda. JMIR Mhealth Uhealth. 2016 Feb 15;4(1):e16. doi: 10.2196/mhealth.5167.
- Wiens MO, Kumbakumba E, Larson CP, Moschovis PP, Barigye C, Kabakyenga J, Ndamira A, English L, Kissoon N, Zhou G, Ansermino JM. Scheduled Follow-Up Referrals and Simple Prevention Kits Including Counseling to Improve Post-Discharge Outcomes Among Children in Uganda: A Proof-of-Concept Study. Glob Health Sci Pract. 2016 Sep 29;4(3):422-34. doi: 10.9745/GHSP-D-16-00069. Print 2016 Sep 28.
- Matthew Wiens 2017. "Smart Discharges to Improve Post-discharge Health Outcomes in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730452.
Frequently Asked Questions
Is the sample population for this research limited to individuals aged 40 or older?
"We are looking for participants who range in age from 0 days to 59 months." - Anonymous Online Contributor
Who qualifies to be a participant in this clinical investigation?
"This trial is recruiting 117 hundred participants with sepsis, aged between 0 days and 59 months old. To be considered eligible for the study, potential patients must meet these requirements." - Anonymous Online Contributor
Are there any current opportunities to participate in this clinical experiment?
"According to the records on clinicaltrials.gov, this medical trial is currently open for recruitment and was initially posted in July of 2017, with its last update occurring in February of 2023." - Anonymous Online Contributor
How many individuals are partaking in this investigation?
"Affirmative, clinicaltrials.gov data reveals that this experiment is currently enrolling patients. The trial was first posted on July 16th 2017 and recently updated on February 14th 2023. Over 11700 participants need to be recruited from 1 medical centre." - Anonymous Online Contributor