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)

Neonatal Respiratory Distress Clinical Trial

Official title:

A Pilot 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04096235
• Other study ID #: E-19-763
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neonatal Respiratory Distress
• Respiratory Distress Syndrome, Newborn

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