Status:
NOT_YET_RECRUITING
Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants
Lead Sponsor:
Charles University, Czech Republic
Conditions:
Premature; Infant
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal s...
Detailed Description
Background and Rationale The stabilization of very premature infants (VPIs) immediately after birth is crucial, as their underdeveloped lungs are prone to respiratory distress. Non-invasive continuou...
Eligibility Criteria
Inclusion
- Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.
- Written informed consent from parent/legal guardian(s) is obtained before delivery.
Exclusion
- Peripartal hypoxia with pH \< 7,1
- Significant congenital malformations.
- IUGR with estimated weight of fetus below 800g.
- Condition that has an adverse effect on breathing/ventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.
- Documented decision to give palliative neonatal care.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT06543589
Start Date
December 1 2024
End Date
September 1 2026
Last Update
November 12 2024
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