Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/26/2018 |
| Start Date: | September 19, 2016 |
| End Date: | September 2026 |
| Contact: | Donald Null, MD |
| Email: | dnull@UCDAVIS.EDU |
| Phone: | 385-215-6233 |
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
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
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
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.
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.
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
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