Status:
TERMINATED
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)
Lead Sponsor:
Englewood Hospital and Medical Center
Conditions:
Neonatal Respiratory Distress
Eligibility:
All Genders
28-42 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04096235
Start Date
October 18 2019
End Date
July 8 2021
Last Update
August 20 2021
Active Locations (1)
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1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631