Status:
COMPLETED
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns
Lead Sponsor:
Erebouni Medical Center
Collaborating Sponsors:
Fisher and Paykel Healthcare
Conditions:
RDS - Infants
TTN
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns. Safe and effective use of NHF requires selection of an appropriate nasal prong-to-na...
Detailed Description
NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applie...
Eligibility Criteria
Inclusion
- Term and near term newborns with respiratory distress receiving treatment with NHF
- ≤ 48 hours old
- FiO2 ≥ 0,4
- Written parental informed consent
Exclusion
- Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
- Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- A parent has not given written informed consent to their baby's participation.
- Prior intubation and/or surfactant administration
- Known or suspected hypoxic ischemic encephalopathy
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04459429
Start Date
June 26 2020
End Date
December 24 2020
Last Update
June 30 2021
Active Locations (1)
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1
Erebouni Medical Center Maternity
Yerevan, Armenia, 0087