Status:
COMPLETED
Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study
Lead Sponsor:
Prince of Songkla University
Conditions:
High-Frequency Ventilation
Intermittent Positive-Pressure Ventilation
Eligibility:
All Genders
1-1 years
Phase:
NA
Brief Summary
Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ve...
Detailed Description
The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.
Eligibility Criteria
Inclusion
- Born in hospital and admit in NICU
- The first endotracheal intubation and need NIV if extubation
- Umbilical arterial catheterization to draw the blood gas
- Neonate has not been intervened from another RCT study
Exclusion
- Major congenital anomalies or chromosomal abnormalities
- Neuromuscular diseases
- Upper respiratory tract abnormalities
- Suspected congenital lung diseases or pulmonary hypoplasia
- Need for surgery known before the first extubation
- Grade IV intraventricular hemorrhage occurring before the first extubation
- Palliative care
- Parents' decision not to participate
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04323397
Start Date
July 1 2020
End Date
August 1 2022
Last Update
March 3 2025
Active Locations (1)
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1
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110