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High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

ConditionsPremature InfantVentilation TherapyHigh Flow Nasal Canula
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorCharles University, Czech Republic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Preterm infants born between 25+0 and 27+6 gestational weeks

Weight above 500 grams

Disqualifiers

Previable rupture of membranes,

Congenital malformations previable

Acute intrauterine hypoxia.

Trial design

Design model

Single group

Treatments tested in this trial

  • High-Flow Nasal Cannula

    Device

    The intervention involves administering High-Flow Nasal Cannula therapy to extremely preterm infants immediately after birth.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: High-flow-nasal-cannulaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Positive pressure ventilation after delivery

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

Time frame
10 minutes

Secondary outcomes

1

SpO₂ > 80% in five minutes after delivery

The number of infants with SpO₂ \> 80% five minutes after delivery, with or without the use of positive pressure ventilation (PPV).

Time frame
5 minutes
2

SpO₂ > 90% ten minutes after delivery

The number of infants with SpO₂ \> 90% ten minutes after delivery without the use of positive pressure ventilation (PPV).

Time frame
10 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: