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

NCT03870243 | Completed DMC

• 1 other identifier: PR-18052
• Study Type: interventional
• Target: 1,240
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Pneumonia

Keywords

Bubble CPAP; Young Children; Severe Pneumonia; Hypoxemia; Treatment failure; Mortality

Outcome Measures

Primary Outcomes (2)

• 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

  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

  7 months

• For stage III: Primary outcome: Treatment failure

  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.

  12-18 months (Mid April 2021 to Mid October 2022)

Secondary Outcomes (1)

• Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered

  12-18 months (Mid April 2021 to Mid October 2022)

Other Outcomes (4)

• Length of hospital stay in days

  12-18 months (Mid April 2021 to Mid October 2022)

• Incidence of nasal trauma, gastric distention, shock and air leaks in number

  12-18 months (Mid April 2021 to Mid October 2022)

• Duration of bCPAP in hour

  12-18 months (Mid April 2021 to Mid October 2022)

Study Arms (2)

Bubble CPAP

ACTIVE COMPARATOR

6 hospitals will be selected randomly for this arm

Device: Bubble CPAP

Low flow oxygen

ACTIVE COMPARATOR

6 hospitals will be selected for low flow oxygen therapy

Device: Low flow oxygen

Interventions

Bubble CPAP DEVICE

To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia

Bubble CPAP

Low flow oxygen DEVICE

To see the effectiveness of low flow oxygen in children with severe pneumonia

Low flow oxygen

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Armauer Hansen Research Institute (AHRI), Ethiopia: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Mohakhali, 1212, Bangladesh

Location

Related Publications (25)

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• 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

  BACKGROUND

• Gebre M, Haile K, Duke T, Faruk MT, Kamal M, Kabir MF, Uddin MF, Shimelis M, Beyene T, Solomon B, Solomon M, Bayih AG, Abdissa A, Balcha TT, Argaw R, Demtse A, Weldetsadik AY, Girma A, Haile BW, Shahid ASMSB, Ahmed T, Clemens JD, Chisti MJ. Effectiveness of bubble continuous positive airway pressure for treatment of children aged 1-59 months with severe pneumonia and hypoxaemia in Ethiopia: a pragmatic cluster-randomised controlled trial. Lancet Glob Health. 2024 May;12(5):e804-e814. doi: 10.1016/S2214-109X(24)00032-9. Epub 2024 Mar 21.

  PMID: 38522443 DERIVED

MeSH Terms

Conditions

Pneumonia; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammod Jobayer Chisti, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As it was an open-labeled randomized controlled clinical trial, there was no masking in any intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 12, 2019
• Study Start: September 2, 2019
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)