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)

Englewood Hospital and Medical Center14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neonatal Respiratory Distress

Interventions

RAM Nasal CannulaOTHER

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

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 42 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 5 days

Secondary Outcomes

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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

Time frame: 5 days