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Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia (Child-bCPAP)

Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia

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

Objective:

  1. To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial.
  2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
  3. To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia.
  4. To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals.

Methodology:

Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.

Outcome:

  1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
  2. To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh.
  3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
  4. A qualitative assessment of the feasibility of introducing bubble CPAP.

Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)

Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.

Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.

Study duration: 44 months

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Observationnel

Inscription (Réel)

20

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Dhaka, Bengladesh, 1212
        • Institute of Child and Mother Health
      • Kustia, Bengladesh
        • 250 bedded General hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 mois à 2 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)

La description

INCLUSION CRITERIA

  • Staff:

    • Staff (medical and nursing) employed at the two selected hospitals with duties that include care of children with pneumonia
    • Staff who agree to participate and give written informed consent
  • Children for assessment of hypoxaemia in pneumonia and outcomes:

    • Age between 2 - 24 months
    • Attend one of the two study hospitals for the assessment of pneumonia by hospital clinician.
    • Pneumonia defined by WHO criteria
  • Children receiving bubble CPAP:

    • Age between 2 - 24 months.
    • Diagnosis of pneumonia by a hospital clinician together with hypoxaemia (SpO2<90%).
    • Parent/guardian gives informed consent to participate in the study

EXCLUSION CRITERIA

  • Hospital staff:

    o There will be no exclusion criteria

  • Children for assessment of hypoxaemia in pneumonia and outcomes, and children receiving bubble CPAP:

    • Known congenital heart disease, asthma, pulmonary TB and other chronic respiratory disorders

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
bubble CPAP arm

Oxygen will be delivered by Bubble CPAP device, which will have three components:

  1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
  2. A nasal interface connecting the child's airway with the circuit: short nasal prongs are generally used to deliver nasal CPAP. They must be carefully fitted to minimize leakage of air (otherwise, CPAP will not be achieved) .
  3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure: in bubble CPAP, the positive pressure is maintained by placing the far end of the expiratory tubing in water. The pressure is adjusted by altering the depth of the tube under the surface of the water.

In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child.

The system has three components:

  1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
  2. A nasal interface connecting the child's airway with the circuit:
  3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure.

The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The structural, functional and operational challenges will be described
Délai: 44 month
Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
44 month
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh
Délai: 44 month
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
44 month
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Délai: 44 month
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
44 month
Feasibility and acceptability of introducing bubble CPAP
Délai: 44 month
Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
44 month

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2018

Achèvement primaire (Réel)

31 décembre 2021

Achèvement de l'étude (Réel)

31 décembre 2021

Dates d'inscription aux études

Première soumission

16 octobre 2018

Première soumission répondant aux critères de contrôle qualité

3 février 2022

Première publication (Réel)

15 février 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 février 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 février 2022

Dernière vérification

1 décembre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

After the end of the study, data will be analyzed as ter the defined data analysis plan on the protocol. Study results will be shared with other researchers by journal publications, conferences proceedings and dissemination programs

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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