Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.
Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.
Written informed consent from parent/legal guardian(s) is obtained before delivery.
Peripartal hypoxia with pH < 7,1
Significant congenital malformations.
IUGR with estimated weight of fetus below 800g.
Condition that has an adverse effect on breathing/ventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.
Sequential
High-flow-nasal-cannula
DeviceRespiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L/ min via binasal cannula.
Positive pressure ventilation (PPV)
The primary endpoint of the trial is to demonstrate a difference in the proportion of neonates requiring PPV administration in the delivery room during the first 10 minutes post-birth. This will be recorded as a binary outcome (yes/no) indicating whether PPV was administered. Each neonate's need for PPV should be documented by the clinical team and recorded in a standardized data collection form immediately after delivery.
SpO2 >80% within the first 5 minutes of life
Achieving SpO2 \>80% within the first 5 minutes of life, regardless of FiO2 without the need of PPV administration. Oxygen saturation (SpO₂) will be measured continuously using a pulse oximeter attached to the infant.
SpO2 >90% with FiO2 ≤ 0.40 within the first 10 minutes of life
Achieving SpO2 \>90% with FiO2 ≤ 0.40 within the first 10 minutes of life without the need for PPV. Oxygen saturation (SpO₂) will be measured continuously using a pulse oximeter attached to the infant.
Stabilization on selected ventilatory support
Stabilization on selected ventilatory support with FiO2 ≤ 0.35 without the use of PPV at 3h of life. FiO₂ and respiratory support (CPAP or HFNC) will be documented.
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