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

Sponsor

University of California, Davis (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03711565

Collaborator

(none)

Enrollment

Location

Arms

119.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neonatal Respiratory Distress Related Conditions	Device: Regular Nasal CPAP using a conventional ventilator Device: High Frequency Nasal CPAP	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 19, 2016

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: Regular Nasal CPAP using a conventional ventilator 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
Active Comparator: 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	Device: 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 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.

Arm

Intervention/Treatment

Active Comparator: 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

Device: Regular Nasal CPAP using a conventional ventilator

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

Active Comparator: 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

Device: 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 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Health	Sacramento	California	United States	95817

Sponsors and Collaborators

University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT03711565

Other Study ID Numbers:

828375

First Posted:

Oct 18, 2018

Last Update Posted:

Apr 6, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by University of California, Davis

Nasal CPAP

High Frequency NCPAP

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn

Respiratory Distress Syndrome

Study Results

No Results Posted as of Apr 6, 2021