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)
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 |
Verified date | August 2021 |
Source | Englewood Hospital and Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Englewood Hospital and Medical Center |
United States,
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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