An interventional study of Non-invasive respiratory support in Respiratory Distress Syndrome and Premature Birth, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 94 is above the median of 60 across 960 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Assiut University is the lead sponsor of 4,919 studies on the registry; 2,116 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface.
Device: Non-invasive respiratory support
Preterm infants will receive heated and humidified high-flow nasal cannula therapy.
Device: Non-invasive respiratory support
Non-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation.
Treatment failure within 72 hours
Number of infants meeting predefined criteria for treatment failure of the assigned non-invasive respiratory support modality within the first 72 hours.
Time frame: At 72 hours
Need for mechanical ventilation
Number of infants requiring endotracheal intubation and mechanical ventilation.
Time frame: At 72 hours
Need for surfactant therapy
Number of infants requiring surfactant administration.
Time frame: At 72 hours
Duration of respiratory support
Mean duration of non-invasive respiratory support in days.
Time frame: At 28 days
Incidence of nasal trauma
Number of infants who develop nasal trauma related to the respiratory support interface.
Time frame: At 28 days
Incidence of pneumothorax
Number of infants who develop pneumothorax.
Time frame: At 28 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Assiut University