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

July 3, 2026 updated by: Kayseri City Hospital

Heated Humidified High-Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure as Primary Respiratory Support in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Turkey (Türkiye), 38090
        • Kayseri City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 Heated humidified high-flow nasal cannula (HHHFNC)
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%.
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%.
Other Names:
  • Vapotherm Precision Flow Hi-VNI
Active Comparator: Group 2 Nasal continuous positive airway pressure (nCPAP)
n:43 nCPAP via ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to 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%.
Other Names:
  • nCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Time Frame: 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.
First 7 days of life (assessed at 72 hours, Day 5, and Day 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Nasal Trauma
Time Frame: 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.
During noninvasive respiratory support (first 7 days of life)
Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
Time Frame: 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.
From 72 hours of life through hospital discharge, an average of 24 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time Frame: At 36 weeks postmenstrual age
BPD defined as an oxygen requirement at 36 weeks postmenstrual age.
At 36 weeks postmenstrual age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
Time Frame: From randomization through hospital discharge, an average of 24 days
PDA requiring medical or surgical treatment.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Intraventricular Hemorrhage (IVH) of Any Grade
Time Frame: From randomization through hospital discharge, an average of 24 days
IVH of any grade detected on cranial ultrasound.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Necrotizing Enterocolitis (NEC) of Any Stage
Time Frame: From randomization through hospital discharge, an average of 24 days
NEC of any stage.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Retinopathy of Prematurity (ROP)
Time Frame: From randomization through hospital discharge, an average of 24 days
ROP of any stage on ophthalmologic examination.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Periventricular Leukomalacia (PVL)
Time Frame: From randomization through hospital discharge, an average of 24 days
PVL detected on cranial imaging.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Feeding Intolerance
Time Frame: From randomization through hospital discharge, an average of 24 days
Feeding intolerance per pre-specified clinical criteria.
From randomization through hospital discharge, an average of 24 days
Days to Full Enteral Feeding
Time Frame: From birth until full enteral feeding is achieved, an average of 8 days
Number of days from birth to achievement of full enteral feeding (>=120 mL/kg/day).
From birth until full enteral feeding is achieved, an average of 8 days
Duration of Total Parenteral Nutrition (TPN)
Time Frame: From birth through hospital discharge, an average of 24 days
Total duration of parenteral nutrition, in days.
From birth through hospital discharge, an average of 24 days
Duration of Total Oxygen Support
Time Frame: From randomization through hospital discharge, an average of 24 days
Total duration of any oxygen support, in days.
From randomization through hospital discharge, an average of 24 days
Number of Participants With All-Cause In-Hospital Mortality
Time Frame: From randomization through hospital discharge, an average of 24 days
All-cause mortality during hospitalization.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Air Leak Syndrome
Time Frame: First 7 days of life (respiratory support period)
Air leak syndrome, including pneumothorax.
First 7 days of life (respiratory support period)
Number of Participants With Clinically Significant Apnea
Time Frame: First 7 days of life (respiratory support period)
Clinically significant apnea episodes.
First 7 days of life (respiratory support period)
Discharge Weight
Time Frame: At hospital discharge, an average of 24 days after randomization
Body weight at hospital discharge, in grams.
At hospital discharge, an average of 24 days after randomization
Hospital Length of Stay
Time Frame: From randomization through hospital discharge, an average of 24 days
Total length of hospital stay, in days.
From randomization through hospital discharge, an average of 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethics C.D.No:141(Kayseri CH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are not publicly available due to privacy and ethical restrictions but are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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