NCT06683677
Not yet recruiting
Not Applicable
High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Extremely Premature Infants: a Prospective Observational Study
Charles University, Czech Republic1 site in 1 country60 target enrollmentDecember 1, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Infant
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Positive pressure ventilation after delivery
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low Saturation of oxygen (SpO2).
Investigators
Jonáš Klára
Principal Investigator
Charles University, Czech Republic
Eligibility Criteria
Inclusion Criteria
- •Preterm infants born between 25+0 and 27+6 gestational weeks
- •Weight above 500 grams
Exclusion Criteria
- •Previable rupture of membranes,
- •Congenital malformations previable
- •Acute intrauterine hypoxia.
Outcomes
Primary Outcomes
Positive pressure ventilation after delivery
Time Frame: 10 minutes
The number of infants who required positive pressure ventilation (PPV) in the first ten minutes after delivery.
Secondary Outcomes
- SpO₂ > 80% in five minutes after delivery(5 minutes)
- SpO₂ > 90% ten minutes after delivery(10 minutes)
Study Sites (1)
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