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Completed

NCT Number: NCT02208323

Advancement of Modified Bubble CPAP

This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.

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Key information

Conditions

Hypoxia Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gulu Regional Referral Hospital

Gulu, Uganda

About this study

This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3

Exclusion criteria

  • Pneumothorax
  • Congenital lung disease
  • Cyanotic heart disease
  • Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
  • Nasal tissue injury
  • Active nosebleed
  • Recent abdominal surgery or significant abdominal distension
  • Agonal respirations
  • GCS <3
  • Imminent death within the next 1-2hou

Treatment and study plan

Bubble CPAP

Device

Respiratory assistance

Primary outcomes

  1. determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period

    Time frame: 28 days

    A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale

Secondary outcomes

  1. show decreased mortality in patients treated with a modified bCPAP respiratory support device.

    Time frame: 28 days

    Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2014
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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