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Completed

NCT Number: NCT07693530

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

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.

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Key information

Conditions

Premature Birth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Urogenital Diseases

Age range

28 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, 38090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm infants admitted to the NICU who fulfilled all of the following were eligible:

  • Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g
  • Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS)
  • Silverman-Anderson score (SAS) 4 < SAS < 7
  • Eligibility for noninvasive ventilatory support

Exclusion criteria

  • Parental refusal of consent
  • Outborn infants transferred from other centers
  • Infants who required immediate intubation in the delivery room
  • Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects
  • Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip)
  • Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3)
  • Infants who died unexpectedly shortly after admission without respiratory evaluation

Treatment and study plan

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%.

Other names: Vapotherm Precision Flow Hi-VNI

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%.

Other names: nCPAP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of Participants With Periventricular Leukomalacia (PVL)

    Time frame: From randomization through hospital discharge, an average of 24 days

    PVL detected on cranial imaging.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. Number of Participants With Air Leak Syndrome

    Time frame: First 7 days of life (respiratory support period)

    Air leak syndrome, including pneumothorax.

  12. Number of Participants With Clinically Significant Apnea

    Time frame: First 7 days of life (respiratory support period)

    Clinically significant apnea episodes.

  13. Discharge Weight

    Time frame: At hospital discharge, an average of 24 days after randomization

    Body weight at hospital discharge, in grams.

  14. Hospital Length of Stay

    Time frame: From randomization through hospital discharge, an average of 24 days

    Total length of hospital stay, in days.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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