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

• ClinicalTrials.gov Identifier: NCT03711565
• Recruitment Status: Withdrawn
• First Posted: October 18, 2018
• Last Update Posted: April 6, 2021
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

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	Not Applicable

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 (Clinical Trial)
• 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: September 19, 2016
• Estimated Primary Completion Date: September 2026
• Estimated Study Completion Date: September 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.

Outcome Measures

Primary Outcome Measures :

1. Respiratory Index Score (RSI) [ Time Frame: 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

• Ages Eligible for Study: up to 4 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

UC Davis Health

Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03711565
• Other Study ID Numbers: 828375
• First Posted: October 18, 2018
• Last Update Posted: April 6, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• 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; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases