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

NCT07693530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Group 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%.

DEVICE

Group 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 & Collaborators

  • Kayseri City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-05-01
Completion
2022-05-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693530 on ClinicalTrials.gov