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nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS

NCT07869719 — Not applicable, Not yet recruiting, 94 participants, Assiut University
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Comparison Between the Use of nCPAP and High-Flow Nasal Cannula in Preterm Infants With Respiratory Distress Syndrome in the NICU

RegistryNCT07869719
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment94 (Estimated)
SponsorAssiut University (Other)
ConditionsRespiratory Distress Syndrome, Premature Birth
InterventionsNon-invasive respiratory support (Device)
Datesstart 2026-10-10 (estimated), primary completion 2027-10-10 (estimated), completion 2028-02-25 (estimated), first posted 2026-10-09, last updated 2026-10-09

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-Summary

This randomized controlled trial aims to compare the efficacy and safety of nasal continuous positive airway pressure versus high-flow nasal cannula as initial non-invasive respiratory support in preterm infants with respiratory distress syndrome.

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+Detailed description

Respiratory distress syndrome is a major cause of morbidity in preterm infants. Non-invasive respiratory support with nasal continuous positive airway pressure (nCPAP) or high-flow nasal cannula (HFNC) is commonly used to avoid intubation.

This prospective randomized parallel-group trial will compare treatment failure rates within the first 72 hours between preterm infants receiving nCPAP and those receiving HFNC as initial respiratory support.

+Arms and interventions

ArmTypeInterventionsDescription
Nasal Continuous Positive Airway PressureExperimentalDevice: Non-invasive respiratory supportPreterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface.
High-Flow Nasal CannulaActive comparatorDevice: Non-invasive respiratory supportPreterm infants will receive heated and humidified high-flow nasal cannula therapy.
  • Non-invasive respiratory support (Device): Non-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation.

+Outcome measures

Primary outcomes

  • Treatment failure within 72 hours [At 72 hours]: Number of infants meeting predefined criteria for treatment failure of the assigned non-invasive respiratory support modality within the first 72 hours.

Secondary outcomes

  • Need for mechanical ventilation [At 72 hours]: Number of infants requiring endotracheal intubation and mechanical ventilation.
  • Need for surfactant therapy [At 72 hours]: Number of infants requiring surfactant administration.
  • Duration of respiratory support [At 28 days]: Mean duration of non-invasive respiratory support in days.
  • Incidence of nasal trauma [At 28 days]: Number of infants who develop nasal trauma related to the respiratory support interface.
  • Incidence of pneumothorax [At 28 days]: Number of infants who develop pneumothorax.

+Eligibility

Sex: All, ages: any to 28 Days

Inclusion Criteria:

* \- Preterm infants with gestational age 28 to 36 weeks and 6 days
* Clinical diagnosis of respiratory distress syndrome
* Spontaneous breathing without immediate need for invasive mechanical ventilation
* Requirement for non-invasive respiratory support
* Written informed consent from parent or legal guardian

Exclusion Criteria:

* \- Infants requiring immediate endotracheal intubation and mechanical ventilation
* Major congenital anomalies affecting the respiratory or cardiovascular systems
* Congenital diaphragmatic hernia
* Significant congenital heart disease
* Severe perinatal asphyxia requiring prolonged resuscitation
* Severe hemodynamic instability
* Prolonged mechanical ventilation before enrollment

+Investigators

My Notes