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Comparison of CPAP Machines With Reusable vs Disposable Circuits

NCT03121612 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-11-20

Study results available
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Summary

The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress syndrome. The assessment will compare a comprehensive list of physiological parameters over the first 72 hours of treatment, and will also monitor rates of side effects and adverse events. The null hypothesis is that infants treated on the two categories of machine (reusable vs disposable) will not differ in relation to key physiological parameters by more than 0.63 standard deviations.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DEVICE

CPAP

CPAP therapy

Sponsors & Collaborators

  • MS Ramaiah Medical College & Hospitals

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Medical Technology Transfer and Services Hong Kong Ltd

    lead INDUSTRY

Principal Investigators

  • G CM Pradeep, MD · MS Ramaiah Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-08-15
Completion
2018-10-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03121612 on ClinicalTrials.gov