NCT01839474

Brief Summary

The purpose of this study is to determine if the use of a continuous positive airway pressure (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying from difficulty breathing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 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

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

April 22, 2013

Last Update Submit

February 2, 2017

Conditions

PneumoniaAcute Respiratory Infection

Keywords

Continuous Positive Airway PressureControlled trialPneumoniaChildren

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    The primary outcome will be 2 week mortality rate in children receiving CPAP and standard therapy compared with children receiving standard therapy alone.

    2 weeks

Secondary Outcomes (1)

  • Respiratory rate

    24 hours

Other Outcomes (1)

  • Evidence of viral respiratory infection

    baseline (at time of enrolment)

Study Arms (2)

CPAP

EXPERIMENTAL

Children will be placed on nasal CPAP until they have an age appropriate respiratory rate and receive standard medical therapy.

Device: CPAP

Control

NO INTERVENTION

Children will receive standard medical therapy.

Interventions

CPAPDEVICE

Appropriately sized nasal prongs will be selected for the patient, gently applied ensuring a tight seal, and securely fastened. The CPAP machine will be turned on to deliver a pressure of 5 cm H2O in the inspiratory limb of the system. Patients will be allowed to be in the position of most comfort, preferably with mouth closed to maintain pressure in the circuit.

Also known as: Continuous Positive Airway Pressure
CPAP

Eligibility Criteria

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

You may qualify if:

  • One month to five years of age
  • Respiratory rate (RR) greater than 50 breaths per minute in three months to one year of age, and greater than 40 breaths per minute in one to five years of age
  • Presence of sub costal, intercostal, supraclavicular retractions or nasal flaring

You may not qualify if:

  • Age less than one month or older than five years
  • Skin breakdown around nose/mouth or facial trauma
  • Unable to protect airway
  • Uncontrollable emesis
  • Unresponsiveness
  • poor respiratory effort requiring positive pressure ventilation or invasive mechanical ventilation for respiratory failure
  • known or suspected pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mampong District Hospital

Mampong, Ashanti Region, Ghana

Location

Kintampo District Hospital

Kintampo, Brong Ahafo, Ghana

Location

Related Publications (1)

  • Wilson PT, Baiden F, Brooks JC, Morris MC, Giessler K, Punguyire D, Apio G, Agyeman-Ampromfi A, Lopez-Pintado S, Sylverken J, Nyarko-Jectey K, Tagbor H, Moresky RT. Continuous positive airway pressure for children with undifferentiated respiratory distress in Ghana: an open-label, cluster, crossover trial. Lancet Glob Health. 2017 Jun;5(6):e615-e623. doi: 10.1016/S2214-109X(17)30145-6.

    PMID: 28495265DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Rachel T Moresky, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor of Population & Family Health and Medicine

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

GH(2)