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Completed
NCT07693530
High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
Conditions: Premature Birth, Respiratory Distress Syndrome, Newborn
Sex: All
Ages: 28 Weeks – 34 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 86
Sponsor: Kayseri City Hospital
Location: Kayseri City Hospital Kayseri Kayseri
Summary
This single-center randomized controlled trial compared heated humidified high-flow nasal cannula (HHHFNC) with nasal continuous positive airway pressure (nCPAP) as primary noninvasive respiratory support in preterm infants (gestational age 28-34 weeks; birth weight 1000-2000 g) with moderate respiratory distress syndrome. The primary outcome was treatment failure requiring invasive mechanical ventilation within the first 7 days.
Eligibility Criteria
Inclusion Criteria:
Preterm infants admitted to the NICU who fulfilled all of the following were eligible:
1. Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g
2. Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS)
3. Silverman-Anderson score (SAS) 4 \< SAS \< 7
4. Eligibility for noninvasive ventilatory support
Exclusion Criteria:
1. Parental refusal of consent
2. Outborn infants transferred from other centers
3. Infants who required immediate intubation in the delivery room
4. Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects
5. Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip)
6. Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3)
7. Infants who died unexpectedly shortly after admission without respiratory evaluation
Source: ClinicalTrials.gov (NCT07693530). StuddyBuddy aggregates publicly available trial information.