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

University of California (UC) Davis logo

University of California (UC) Davis

Status

Withdrawn

Conditions

Neonatal Respiratory Distress Related Conditions

Treatments

Device: High Frequency Nasal CPAP
Device: Regular Nasal CPAP using a conventional ventilator

Study type

Interventional

Funder types

Other

Identifiers

NCT03711565
828375

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

Under 4 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Regular Nasal CPAP using a conventional ventilator
Active Comparator group
Description:
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
Treatment:
Device: Regular Nasal CPAP using a conventional ventilator
High Frequency Nasal CPAP
Active Comparator group
Description:
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
Treatment:
Device: High Frequency Nasal CPAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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