High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

Not Applicable

Not yet recruiting

• Conditions: Premature Infant; Ventilation Therapy; High Flow Nasal Canula

• Registration Number: NCT06683677
• Lead Sponsor: Charles University, Czech Republic

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Start: 2024-12-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive pressure ventilation after delivery	10 minutes	The number of infants who required positive pressure ventilation (PPV) in the first ten minutes after delivery.

Secondary Outcome Measures

Name	Time	Method
SpO₂ > 80% in five minutes after delivery	5 minutes	The number of infants with SpO₂ \> 80% five minutes after delivery, with or without the use of positive pressure ventilation (PPV).
SpO₂ > 90% ten minutes after delivery	10 minutes	The number of infants with SpO₂ \> 90% ten minutes after delivery without the use of positive pressure ventilation (PPV).

Trial Locations

Locations (1)

General University Hospital Prague; 🇨🇿 Prague, Czech Republic