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Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia

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ClinicalTrials.gov Identifier: NCT03870243
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : November 22, 2022
Sponsor:
Collaborator:
Armauer Hansen Research Institute (AHRI), Ethiopia
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Principal Investigator: Mohammod Jobayer Chisti

Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial

Proposed start date: 1st July 2018, Estimated end date: 31st December 2022

Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.

Objectives:

Stages I and II

  • To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II
  • To record adverse events following use of bubble CPAP in these settings
  • To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system

Stage III:

  • To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia
  • To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure & mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia
  • To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.

Condition or disease Intervention/treatment Phase
Severe Pneumonia Device: Bubble CPAP Device: Low flow oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children aged 1-59 months with Severe Pneumonia in Ethiopia, divided in two arms; one arm will get bCPAP other arm will get WHO recommended low flow oxygen.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In stage III among 12 district hospitals, 6 hospitals will randomly selected for bubble CPAP and another 6 hospitals will get low flow oxygen therapy. Masking of the personnel who are related to the study will be maintained from beginning.
Primary Purpose: Treatment
Official Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial
Actual Study Start Date : September 2, 2019
Actual Primary Completion Date : July 27, 2022
Actual Study Completion Date : July 27, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bubble CPAP
6 hospitals will be selected randomly for this arm
Device: Bubble CPAP
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia

Active Comparator: Low flow oxygen
6 hospitals will be selected for low flow oxygen therapy
Device: Low flow oxygen
To see the effectiveness of low flow oxygen in children with severe pneumonia




Primary Outcome Measures :
  1. For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage [ Time Frame: 7 months ]
    Patient level and health professional level challenge is the outcome of phase I and II. All will be measured in number and reported in percentage. For stage I and II: Primary outcome: operational challenges that may include availability of pulse oxymetry, IV cannula, IV antibiotics, oxygen supply system and nasal catheters for treating severe pneumonia Secondary outcomes: prevalence of severe pneumonia associated hypoxemia, their treatment practices, adverse events, mortality and treatment failure

  2. For stage III: Primary outcome: Treatment failure [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]

    According to this protocol treatment failure will be declared if the following criteria are met:

    A. Presence of severe hypoxemia (SpO2<85%) at any time after at least one hour of intervention plus severe respiratory distress when the child is receiving BCPAP/LF OR, B. If the patient developed the indication of mechanical ventilation when the child is receiving BCPAP/LF OR, C. If the patient died during hospitalization OR, D. If the patient left against medical advice (LAMA) due to lack of improvement or deterioration of the child during hospitalization

    All will be measured in number and reported in percentage.



Secondary Outcome Measures :
  1. Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]
    All will be measured in number and reported in percentage.


Other Outcome Measures:
  1. Length of hospital stay in days [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]
    Length of hospital stay will be measured and reported in days.

  2. Incidence of nasal trauma, gastric distention, shock and air leaks in number [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]
    Incidence of nasal trauma, gastric distention, shock and air leaks will be measured in number and reported in percentage.

  3. Duration of bCPAP in hour [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]
    Duration of bCPAP will be measured and reported in hour/hours.

  4. Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage [ Time Frame: 12-18 months (Mid April 2021 to Mid October 2022) ]
    Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 1 month and 59 months,
  • Meet WHO clinical criteria for severe pneumonia with hypoxemia.
  • Oxygen saturation <90% despite standard flow oxygen therapy
  • Parent/guardian gives informed consent to participate in the study

Exclusion Criteria:

  • Known congenital heart disease, asthma, or upper -airway obstruction
  • Tracheostomy
  • Pneumothorax
  • Needs mechanical ventilation for any specific reason as decided by the clinician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870243


Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Mohakhali, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Armauer Hansen Research Institute (AHRI), Ethiopia
Investigators
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Principal Investigator: Mohammod Jobayer Chisti, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Publications:
UNICEF. Committing to Child Survival: A Promise Renewed. Progress Report 2015 2015
Chisti MJ, Duke T, Ahmed T, Shahunja KM, Shahid ASMSB, G. FAS, et al. The Use of Bubble CPAP and Humidified High Flow Nasal Cannula Oxygen Therapy in Children with Severe Pneumonia and Hypoxemia: A Systematic Review of the Evidence. Bangladesh Crit Care J. 2014; 2:71-8
Federal Democratic Republic of Ethiopia Ministry of Health. Integrated Management of Newborn and Childhood Illness, Part 1 Blended Learning Module for the Health Extension Programme

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03870243    
Other Study ID Numbers: PR-18052
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share the final outcome after completing the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Bubble CPAP
Young Children
Severe Pneumonia
Hypoxemia
Treatment failure
Mortality
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases