High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome

Kayseri City Hospital

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn; Premature Birth

Treatments: Device: Group 2 Nasal continuous positive airway pressure (nCPAP); Device: Group 1 Heated humidified high-flow nasal cannula (HHHFNC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07693530

Ethics C.D.No:141(Kayseri CH)

Details and patient eligibility

About

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.

Full description

Eighty-six infants were randomized 1:1 to HHHFNC (n=43) or nCPAP (n=43). Both arms followed identical surfactant, escalation, and weaning protocols. Outcomes included treatment failure, nasal trauma, sepsis, feeding intolerance, and time to full enteral feeding.

Enrollment: 86 patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Group 1 Heated humidified high-flow nasal cannula (HHHFNC)

Experimental group

Description:

n:43 Vapotherm Precision Flow Hi-VNI; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO₂ titrated to SpO₂ 91-95%.

Treatment:

Device: Group 1 Heated humidified high-flow nasal cannula (HHHFNC)

Group 2 Nasal continuous positive airway pressure (nCPAP)

Active Comparator group

Description:

n:43 nCPAP via ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to SpO2 91-95%.

Treatment:

Device: Group 2 Nasal continuous positive airway pressure (nCPAP)