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)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Neonatal Respiratory Distress
• Intervention / Treatment: Other: RAM Nasal Cannula

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2019
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: E-19-763

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No