High Flow Nasal Cannula for Stabilization of Extremely Premature Infants (SIMPLSAFE2)

Charles University, Czech Republic

Status: Not yet enrolling

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

Treatments: Device: High-Flow Nasal Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT06683677

16/24

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: Under 2 minutes old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

High-flow-nasal-cannula

Experimental group

Description:

Extremely preterm infants receive High-Flow Nasal Cannula therapy immediately after birth. The intervention includes placental transfusion, followed by administering High-Flow Nasal Cannula at a flow rate of 8 l/min along with intermittent tactile stimulation. Criteria for switching to Continuous Positive Airway Pressure or Positive Pressure Ventilation are established for cases of persistent bradycardia or low Saturation of oxygen (SpO2).

Treatment:

Device: High-Flow Nasal Cannula