NCT03851783

Brief Summary

Globally, approximately 7.7 million children per year die before the age of 5 years. Infectious diseases account for a large proportion of these deaths, with pneumonia being the leading cause of mortality (2.1 million deaths/year). Most deaths occur in resource-poor settings in Asia and Africa. Oxygen (O2) therapy is essential to support life in these patients. Large gaps remain in the case management of children presenting to African hospitals with respiratory distress, including essential supportive therapies such as supplemental oxygen. In resource-constrained settings, oxygen delivery systems can lead to measurable improvements in survival from childhood pneumonia. A multihospital effectiveness study in Papua New Guinea demonstrated a reduction in mortality from childhood pneumonia from 5.0% to 3.2% (35% reduction in mortality) after implementation of enhanced oxygen delivery system. The investigators propose to investigate a novel strategy for oxygen delivery that could be implemented in remote locations with minimal access to an electrical power supply: solar-powered oxygen (SPO2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,405

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

February 21, 2019

Last Update Submit

February 15, 2022

Conditions

PneumoniaHypoxemia

Keywords

solaroxygen

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality at 48 hours after admission

    48 hours

Secondary Outcomes (5)

  • In hospital mortality

    Until end of hospitalization (usually 3 to 7 days)

  • Length of hospital stay

    Until end of hospitalization (usually 3 to 7 days)

  • Oxygen saturation

    Until end of hospitalization (usually 3 to 7 days)

  • Oxygen delivery system failure

    Until end of trial (24 months)

  • Total costs of implementing solar-powered oxygen delivery systems

    Until end of trial (24 months)

Study Arms (2)

Solar-powered oxygen

EXPERIMENTAL

Solar panels used to drive an oxygen concentrator will deliver medical grade oxygen at a rate of 1-5L/min, for the treatment of children with hypoxemia.

Device: Solar-powered oxygen

Standard of care

NO INTERVENTION

Patients presenting with hypoxemia and pneumonia will be treated by standard of care prior to the implementation of solar-powered oxygen at a chosen site. This may include some allocation of oxygen via cylinders, but will likely be minimal or not available.

Interventions

Solar-powered oxygenDEVICE

Constant and reliable administration of oxygen, using solar panels to power an oxygen concentrator and deliver medical grade oxygen at 1-5L/min.

Solar-powered oxygen

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age under 5 years
  • Hypoxemia (SpO2\<92%) based on non-invasive pulse oximetry
  • Hospital admission warranted based on clinician judgment

You may not qualify if:

  • SpO2 ≥92%
  • Outpatient management
  • Denial of consent to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Adumi Health Centre IV

Adumi, Uganda

Location

Apac District Hospital

Apac, Uganda

Location

Atiak Health Centre IV

Atiak, Uganda

Location

Bugobero Health Centre IV

Bugobero, Uganda

Location

Bukedea Health Centre IV

Bukedea, Uganda

Location

Bumanya Health Centre IV

Bumanya, Uganda

Location

Bundibugyo Hospital

Bundibugyo, Uganda

Location

Kagadi Hospital

Kagadi, Uganda

Location

Kalisizo Hospital

Kalisizo, Uganda

Location

Kamuli General Hospital

Kamuli, Uganda

Location

Kayunga District Hospital

Kayunga, Uganda

Location

Kidera Health Centre IV

Kidera, Uganda

Location

Kitagata Hospital

Kitagata, Uganda

Location

Kitgum General Hospital

Kitgum, Uganda

Location

Kyenjojo General Hospital

Kyenjojo, Uganda

Location

Lalogi Health Centre IV

Lalogi, Uganda

Location

Lyantonde Hospital

Lyantonde, Uganda

Location

Gombe Hospital

Mpigi, Uganda

Location

Muyembe Health Centre IV

Muyembe, Uganda

Location

Sembabule Health Centre IV

Sembabule, Uganda

Location

Related Publications (4)

  • Turnbull H, Conroy A, Opoka RO, Namasopo S, Kain KC, Hawkes M. Solar-powered oxygen delivery: proof of concept. Int J Tuberc Lung Dis. 2016 May;20(5):696-703. doi: 10.5588/ijtld.15.0796.

    PMID: 27084827BACKGROUND

  • Hawkes MT, Conroy AL, Namasopo S, Bhargava R, Kain KC, Mian Q, Opoka RO. Solar-Powered Oxygen Delivery in Low-Resource Settings: A Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2018 Jul 1;172(7):694-696. doi: 10.1001/jamapediatrics.2018.0228.

    PMID: 29800014BACKGROUND

  • Conradi N, Opoka RO, Mian Q, Conroy AL, Hermann LL, Charles O, Amone J, Nabwire J, Lee BE, Saleh A, Mandhane P, Namasopo S, Hawkes MT. Solar-powered O2 delivery for the treatment of children with hypoxaemia in Uganda: a stepped-wedge, cluster randomised controlled trial. Lancet. 2024 Feb 24;403(10428):756-765. doi: 10.1016/S0140-6736(23)02502-3. Epub 2024 Feb 14.

    PMID: 38367643DERIVED

  • Conradi N, Mian Q, Namasopo S, Conroy AL, Hermann LL, Olaro C, Amone J, Opoka RO, Hawkes MT. Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda. Trials. 2019 Dec 5;20(1):679. doi: 10.1186/s13063-019-3752-2.

    PMID: 31805985DERIVED

MeSH Terms

Conditions

PneumoniaHypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael T Hawkes, MD, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Robert O Opoka, MBChB, MPH

    Makerere University/Global Health Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge cluster randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 22, 2019

Study Start

July 1, 2019

Primary Completion

December 17, 2021

Study Completion

December 20, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

UG(20)