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

Kayseri City Hospital86 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Premature Birth Respiratory Distress Syndrome, Newborn

Interventions

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

HHHFNC delivered via the Vapotherm Precision Flow Hi-VNI system; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO2 titrated to maintain SpO2 91-95%.

Group 2 Nasal continuous positive airway pressure (nCPAP)DEVICE

nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 34 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation

Treatment failure defined as the need for invasive mechanical ventilation per pre-specified criteria (FiO2 \>=0.60 to maintain SpO2 91-95%; pH \<7.20 with PaCO2 \>60 mmHg; recurrent or caffeine-refractory apnea; markedly increased work of breathing; or clinical deterioration determined by the attending neonatologist), assessed at 72 hours, Day 5, and Day 7 of life.

Time frame: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)

Secondary Outcomes

Number of Participants With Nasal Trauma

Nasal trauma defined as redness, excoriation, bleeding, or crusting at the nasal septum or nares attributed to the respiratory support interface.

Time frame: During noninvasive respiratory support (first 7 days of life)

Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis

Culture-positive late-onset sepsis with onset after 72 hours of life.

Time frame: From 72 hours of life through hospital discharge, an average of 24 days

Number of Participants With Bronchopulmonary Dysplasia (BPD)

BPD defined as an oxygen requirement at 36 weeks postmenstrual age.

Time frame: At 36 weeks postmenstrual age

Data from ClinicalTrials.gov

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