NCT02100865

Brief Summary

Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in resource-poor settings in Africa and Asia. 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. We hypothesize that a novel strategy for oxygen delivery, solar-powered oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen delivery by compressed gas cylinders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

March 27, 2014

Last Update Submit

September 14, 2016

Conditions

PneumoniaHypoxemia

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.

    Until end of hospitalization (usually 3 to 7 days)

Secondary Outcomes (6)

  • Mortality

    At hospital discharge (usually 3 to 7 days)

  • Duration of supplemental oxygen therapy

    Until hospital discharge (usually 3 to 7 days)

  • Proportion of patients successfully oxygenated

    6 hours

  • Oxygen delivery system failure

    During hospitalization (usually 3 to 7 days)

  • Cost

    Until hospital discharge (usually 3 to 7 days)

  • +1 more secondary outcomes

Study Arms (2)

Solar powered oxygen

EXPERIMENTAL

Solar panels used to drive an oxygen concentrator to deliver at stream of oxygen at approximately 90% FiO2 and a rate of 1-5L/min.

Device: Solar powered oxygen

Oxygen from cylinders

ACTIVE COMPARATOR

Conventional oxygen delivery from compressed gas cylinders

Device: Oxygen from cylinders

Interventions

Solar powered oxygenDEVICE
Solar powered oxygen
Oxygen from cylindersDEVICE
Oxygen from cylinders

Eligibility Criteria

AgeUp to 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age \<13 years
  • IMCI defined pneumonia, severe pneumonia or very severe disease
  • Hypoxemia (SpO2\<90%) based on non-invasive pulse oximetry
  • Hospital admission warranted based on clinician judgment
  • Consent to blood sampling and data collection

You may not qualify if:

  • SpO2 ≥90%
  • Suspected pulmonary tuberculosis
  • Outpatient management
  • Denial of consent to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Related Publications (3)

  • Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15.

    PMID: 18708248RESULT

  • 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: 29800014DERIVED

  • Nyende S, Conroy A, Opoka RO, Namasopo S, Kain KC, Mpimbaza A, Bhargava R, Hawkes M. Solar-powered oxygen delivery: study protocol for a randomized controlled trial. Trials. 2015 Jul 9;16:297. doi: 10.1186/s13063-015-0814-y.

    PMID: 26156116DERIVED

Related Links

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

UG(1)