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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.
Full description
Background and Rationale
Non-invasive CPAP is recommended for stabilizing premature newborns, but its optimal pressure is unknown. Higher pressures without spontaneous breathing lead to PPV, which can damage immature lungs and cause complications. Frequent mask adjustments needed for CPAP can stimulate reflexes that exacerbate bradycardia.
HFNC offers a less disruptive alternative, reducing trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness in some premature infants. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for PPV, and support safe and effective stabilization of very premature infants (VPIs).
Hypothesis HFNC reduces upper airway resistance and provides adequate pressure for lung clearance in very immature, spontaneously ventilating neonates. Less irritation compared to CPAP may reduce PPV needs, promoting smooth lung aeration and cardiopulmonary stabilization in very preterm infants.
Trial Aim Compare the effectiveness and safety of HFNC and CPAP in the delivery room and during transport to the NICU in severely premature neonates. The primary endpoint is the proportion of neonates requiring PPV within the first 10 minutes post-birth.
Objectives The primary objective is to compare the effectiveness of HFNC and CPAP in reducing PPV needs in very premature infants immediately after birth.
Study Design A stepped-wedge cluster randomized controlled trial where participating centers are randomized to use both HFNC and CPAP during different periods.
Study Population Setting
10 tertiary referral centers for perinatal care (9 in the Czech Republic, 1 in Slovakia).
Participants
Very premature infants delivered between 28+0 and 31+6 weeks gestation.
Inclusion Criteria
Gestational age between 28+0 and 31+6 weeks. Written informed consent from parents/legal guardians. Exclusion Criteria
Peripartal hypoxia with pH < 7.1. Significant congenital malformations. IUGR with estimated weight below 800g. Conditions affecting breathing/ventilation or oxygenation. Decision for palliative neonatal care. Sample Size Calculation To detect a 15% relative decrease in PPV administration, approximately 443 patients are required. The trial will include five clusters, each recruiting 15 patients per period over 6-10 periods (90 days each).
Recruitment and Consent Centers will be randomized to either CPAP or HFNC at each time period. Parental consent will be obtained before birth, ensuring parents are adequately informed.
Method Primary Endpoint
Proportion of neonates requiring PPV within the first 10 minutes post-birth. Secondary Endpoints
Achieving SpO2 > 80% within 5 minutes without PPV. Achieving SpO2 > 90% with FiO2 ≤ 0.40 within 10 minutes without PPV. Stabilization on selected ventilatory support with FiO2 ≤ 0.35 without PPV at 3 hours of life.
Enrollment
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Inclusion criteria
Infants will be enrolled if they delivered between 28+0 and 31+6 weeks gestation in one of the participating centers. The gestational age of infants was calculated according to the first trimester screening. Written informed consent from parent/legal guardian(s) is obtained before delivery. Infants of multiple gestations and of either sex are eligible to be enrolled
Exclusion criteria
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.
A documented decision to give palliative neonatal care.
Primary purpose
Allocation
Interventional model
Masking
443 participants in 2 patient groups
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Central trial contact
Tereza Lamberska, PhD
Data sourced from clinicaltrials.gov
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