Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

NCT03711565 | Withdrawn FDA Device

• 1 other identifier: 828375
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Controlled randomized trial looking at Standard nasal continuous airway pressure (CPAP) respiratory support versus High Frequency CPAP in neonates who require respiratory support or who are being extubated and require support post extubation. Patients will be evaluated for need to be reintubated and oxygen requirement and PaCO2 levels

Conditions

Neonatal Respiratory Distress Related Conditions

Keywords

Nasal CPAP; High Frequency NCPAP

Outcome Measures

Primary Outcomes (1)

• Respiratory Index Score (RSI)

  The scale is scored based on Fio2 (0 = \<30%, 1 = 30-39%, 2 = 40-49%, 3 = \> or equal to 50%), CPAP/Paw (0 = \<6, 1 = 6-7, 2 = 7-8, 3 = \>8), Spontaneous Respiratory Rate(RR) (0 = \<40, 1 = 40-59, 2 = 60-79, 3 = \> or equal to 80), Retractions (0 = none, 1 = mild, 2 = moderate, 3 = severe), and Apnea (0 = none, 1 = 1/2/2015, 2 = 3/4/2015, 3 = \>4). Average index scores will be compared between conditions.

  72 hours after initiation of support

Study Arms (2)

Regular Nasal CPAP using a conventional ventilator

ACTIVE COMPARATOR

Regular nasal CPAP for management of respiratory distress Patient will have regular nasal CPAP placed via nasal prongs with level of pressure adjusted and level of oxygen adjusted as needed for acceptable oxygenation and ventilation

Device: Regular Nasal CPAP using a conventional ventilator

High Frequency Nasal CPAP

ACTIVE COMPARATOR

High Frequency Nasal CPAP for management of respiratory distress Patient will be connected to the high frequency device through nasal prongs. The pressure, frequency and amplitude of the pulsations will be adjusted as needed to provide acceptable oxygenation and ventilation

Device: High Frequency Nasal CPAP

Interventions

Regular Nasal CPAP using a conventional ventilator DEVICE

The Nasal CPAP is connected to the patient via prongs in the nose. Pressure adjustments are made to improve lung inflation. The frequency and pressure can be adjusted as needed to improve the patient's oxygen and carbon dioxide levels

Regular Nasal CPAP using a conventional ventilator

High Frequency Nasal CPAP DEVICE

High Frequency Nasal CPAP for management of respiratory distress Patient will be connected to the high frequency device through nasal prongs. The Bronchotron produces a pressure that is variable with an adjustable frequency that is equal or greater than 500 times per minute connecting to prongs in the patient's nose. The pressure, frequency and amplitude of the pulsations will be adjusted as needed to provide acceptable oxygenation and ventilation.

High Frequency Nasal CPAP

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn (0-28 days of age) admitted to Neonatal Intensive care unit (NICU)
• Ordered Respiratory treatment of Nasal Continuous Airway Pressure (NCPAP) respiratory support

You may not qualify if:

• Major congenital defect
• Known or suspected chromosomal disorder

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: September 19, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)