Premature Birth, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
HHHFNC, nCPAP, Preterm infant, Noninvasive respiratory support
Brief 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.
Detailed 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.
Interventions
DEVICEGroup 1 Heated humidified high-flow nasal cannula (HHHFNC)
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%.
DEVICEGroup 2 Nasal continuous positive airway pressure (nCPAP)
nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.
Sponsors
Kayseri City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation | First 7 days of life (assessed at 72 hours, Day 5, and Day 7) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nasal Trauma | During noninvasive respiratory support (first 7 days of life) | Nasal trauma defined as redness, excoriation, bleeding, or crusting at the nasal septum or nares attributed to the respiratory support interface. |
| Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis | From 72 hours of life through hospital discharge, an average of 24 days | Culture-positive late-onset sepsis with onset after 72 hours of life. |
| Number of Participants With Bronchopulmonary Dysplasia (BPD) | At 36 weeks postmenstrual age | BPD defined as an oxygen requirement at 36 weeks postmenstrual age. |
Countries
Turkey (Türkiye)
Outcome results
None listed