Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome, Newborn; Low Birth Weight Infants; Continuous Positive Airway Pressure
• Interventions: Device: RAM Cannula; Device: Binasal Prong CPAP

• Registration Number: NCT02168257
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief Summary

The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-20
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Low Birth Weight Infant
• Currently on continuous positive aireway pressure of 5-7 cm water pressure
• Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
• Fraction of inspired oxygen requirement of 23-50%

Exclusion Criteria

• Fraction of inspired oxygen > 50%
• Congenital defects of head, pulmonary or cardiovascular systems
• Chromosomal abnormalities/genetic syndromes
• Invasive Surgical Procedure within 24 hrs prior to enrollment
• Enrollment in separate clinical trial that has ongoing data collection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RAM Cannula CPAP	RAM Cannula	CPAP provided by RAM Cannula
Binasal Prong CPAP	Binasal Prong CPAP	CPAP provided by binasal prong

Primary Outcome Measures

Name	Time	Method
Oxygenation	3 hrs	Pulse oximetry
Ventilation	3 hrs	transcutaneous carbon dioxide monitor

Secondary Outcome Measures

Name	Time	Method
Esophageal pressure measurements	3 hrs	Esophageal Pressure Catheter
Apnea	3 hrs	3-channel pneumogram

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Saint Paul, Minnesota, United States