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

Not Applicable

Withdrawn

• Conditions: Neonatal Respiratory Distress Related Conditions
• Interventions: Device: High Frequency Nasal CPAP; Device: Regular Nasal CPAP using a conventional ventilator

• Registration Number: NCT03711565
• Lead Sponsor: University of California, Davis

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

Detailed Description

This study is a randomized controlled trial comparing High Frequency nasal CPAP versus standard nasal CPAP. The patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. After obtaining parental consent the patient will be randomized to one of the two treatments. Patients will be followed for requirement of level of oxygen and blood gases looking at acidity (pH) and PaCO2 and Bicarbonate(HCO3). A respiratory index score will be measured. Attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. Additionally, frequency, duration and severity of Apnea, Bradycardia and Desaturation events will be recorded. Also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. Also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. This study is not powered to look at long term outcomes.

Study Timeline

• Study Start: 2016-09-19
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Major congenital defect
• Known or suspected chromosomal disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency Nasal CPAP	High Frequency Nasal CPAP	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
Regular Nasal CPAP using a conventional ventilator	Regular Nasal CPAP using a conventional ventilator	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

Primary Outcome Measures

Name	Time	Method
Respiratory Index Score (RSI)	72 hours after initiation of support	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.

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States