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Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC

NCT03620448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-08-08

No results posted yet for this study

Summary

Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).

Conditions

  • Respiratory Distress Syndrome in Premature Infant

Interventions

DEVICE

bCPAP Arm

bCPAP (Rice 360◦c low cost bCPAP device)

OTHER

Oxygen Arm

Oxygen therapy from oxygen cylinders

Sponsors & Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-05-15
Completion
2017-05-15
FDA Device
Yes

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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 NCT03620448 on ClinicalTrials.gov