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)

• Sponsor: Englewood Hospital and Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04096235
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Respiratory Distress	Other: RAM Nasal Cannula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Oct 18, 2019
• Actual Primary Completion Date: Jul 8, 2021
• Actual Study Completion Date: Jul 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RAM Cannula	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.

Outcome Measures

Primary Outcome Measures

1. NCPAP [5 days]

   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.

2. 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 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.

3. NCPAP [5 days]

   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

4. 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

5. 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 SpO2 Level every 3 hours. The SpO2 will be measured in percentage

6. 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

Secondary Outcome Measures

1. High Flow Humidity [5 days]

   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.

2. High Flow Humidity [5 days]

   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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Weeks to 42 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Englewood Hospital and Medical Center	Englewood	New Jersey	United States	07631

Sponsors and Collaborators

• Englewood Hospital and Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Englewood Hospital and Medical Center
• ClinicalTrials.gov Identifier: NCT04096235
• Other Study ID Numbers: E-19-763
• First Posted: Sep 19, 2019
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Study Results

No Results Posted as of Aug 20, 2021