Clinical trial NCT06683677: High Flow Nasal Cannula for Stabilization of Extremely Premature Infants
Official title: High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Extremely Premature Infants: a Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Infant
Ventilation Therapy
High Flow Nasal Canula
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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.

Primary outcomes:
measure: Positive pressure ventilation after delivery
timeFrame: 10 minutes
Secondary outcomes:
measure: SpO₂ > 80% in five minutes after delivery
timeFrame: 5 minutes
measure: SpO₂ > 90% ten minutes after delivery
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: General University Hospital Prague
Study officials:
References:
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