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

Neonatal Respiratory Distress Related Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03711565
• Other study ID #: 828375
• Status: Withdrawn
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: September 2026

Study information

• Verified date: April 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Respiratory Distress Related Conditions
• Respiratory Distress Syndrome, Newborn

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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