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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04096235
Other study ID # E-19-763
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 18, 2019
Est. completion date July 8, 2021

Study information

Verified date August 2021
Source Englewood Hospital and Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date July 8, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers No
Gender All
Age group 28 Weeks to 42 Weeks
Eligibility Inclusion: - Infants with birth weight < 1500 grams AND/OR <32 weeks gestational age - Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion Exclusion: - Infants with major congenital and upper airway anomalies - Infants requiring ETT (endotracheal tube) mechanical ventilation - Infants receiving no respiratory support

Study Design


Related Conditions & MeSH terms


Intervention

Other:
RAM Nasal Cannula
The RAM Nasal Cannula is a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.

Locations

Country Name City State
United States Englewood Hospital and Medical Center Englewood New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary NCPAP The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with the Braden Q score. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale. 5 days
Primary Bi-PAP The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with the Braden Q score every 3 hours. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale. 5 days
Primary NCPAP The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage 5 days
Primary NCPAP 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 5 days
Primary Bi-PAP The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage 5 days
Primary Bi-PAP 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 5 days
Secondary High Flow Humidity The study will determine if the RAM Nasal Cannula administers high flow humidity (>8Ipm) . This will be measured with the Braden Q score, every 3 hours.The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale. 5 days
Secondary High Flow Humidity The study will determine if the RAM Nasal Cannula administers high flow humidity (>8Ipm) . This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters. 5 days
Secondary High Flow Humidity 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 5 days
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