A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)

Not Applicable

Terminated

• Conditions: Neonatal Respiratory Distress
• Interventions: Other: RAM Nasal Cannula

• Registration Number: NCT04096235
• Lead Sponsor: Englewood Hospital and Medical Center

Brief Summary

This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2019-10-18
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAM Cannula	RAM Nasal Cannula	-

Primary Outcome Measures

Name	Time	Method
Bi-PAP	5 days	The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters
NCPAP	5 days	The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters

Secondary Outcome Measures

Name	Time	Method
High Flow Humidity	5 days	The study will determine if the RAM Nasal Cannula administers high flow humidity (\>8Ipm) . This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage

Trial Locations

Locations (1)

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States