NCT03513861: FASTER

Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children

Completed NA Last updated 2 May 2018

What this trial tests

NA trial testing FASTER Assessment tool in Critical Illness in 182 participants. Completed in 30 November 2017.

Timeline

8 May 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	182
Start date	8 May 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across Kenya

Drugs / interventions tested

• FASTER Assessment tool

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Febrile Illness — all drugs for Febrile Illness →

Sponsor

Seattle Children's Hospital

Who can join

Adults 2 Months to 12, any sex, with Critical Illness or Febrile Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this pilot study is to improve inpatient monitoring of severely-ill children admitted to the hospital in low resource settings at Kenyatta National Hospital in Nairobi, Kenya. Given the high ratio of patients to medical staff in these settings, the lack of reliable patient monitoring tools, and the high rate of early inpatient mortality, we will prospectively train parents as monitoring aids of their hospitalized children. Early recognition and intervention in critical illness is important to avoid (further) organ failure. Parents will be taught how to assess their child's mental status, work of breathing and capillary refill time which will inform a 3-point severity of illness scale. The severity of illness will be conveyed by the parents to the medical staff via color-coded flag system. The goal is to increase the healthcare provider patient reassessment rate according to patients' level of severity to assist in early recognition and treatment of patients' deterioration.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Resource Settings-A Two-Arm Interventional Feasibility Study.
   von Saint Andre-von Arnim AO, Kumar RK, Clark JD, Wilfond BS, et al · · 2022 · cited 5× · PMID 35676898 · DOI 10.3389/fped.2022.804346
2. Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-resource settings – a two-arm interventional pilot study
   von Saint Andre-von Arnim AO, Kumar RK, Clark JD, Wilfond BS, et al · · 2021 · DOI 10.1101/2021.11.16.21266433