Respiratory Distress SyndromeNCT07869719
nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS
A study testing Non-invasive respiratory support in people with Respiratory Distress Syndrome and Premature Birth, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome, Premature Birth
- What is being tested?
- Non-invasive respiratory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 25 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between the Use of nCPAP and High-Flow Nasal Cannula in Preterm Infants With Respiratory Distress Syndrome in the NICU
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Premature Birth
- Being tested
- Non-invasive respiratory support
- Keywords
- nCPAP, High-flow nasal cannula, Respiratory distress syndrome, NICU, Assiut, Preterm infants
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive respiratory supportDevice
Non-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Continuous Positive Airway Pressure | Experimental | Preterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface. Receives: Device: Non-invasive respiratory support |
| High-Flow Nasal Cannula | Active comparator | Preterm infants will receive heated and humidified high-flow nasal cannula therapy. Receives: Device: Non-invasive respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 72 hours
Secondary outcomes (5)
Need for mechanical ventilation
Number of infants requiring endotracheal intubation and mechanical ventilation.
Measured: At 72 hours
Need for surfactant therapy
Number of infants requiring surfactant administration.
Measured: At 72 hours
Duration of respiratory support
Mean duration of non-invasive respiratory support in days.
Measured: At 28 days
Incidence of nasal trauma
Number of infants who develop nasal trauma related to the respiratory support interface.
Measured: At 28 days
Incidence of pneumothorax
Number of infants who develop pneumothorax.
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Sabry Mahmoud, Assiut University
- Investigators
- Hekma S Farghaly, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869719
- Sponsor's protocol ID
- nCPAP-HFNC-RDS-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of nCPAP and High-Flow Nasal Cannula in Preterm Infants With Respiratory Distress Syndrome in the NICU
- ClinicalTrials.gov ID
- NCT07869719
- Acronym / sponsor ID
- nCPAP-HFNC-RDS-Assiut-2026
- Conditions
- Respiratory Distress Syndrome, Premature Birth
- Keywords
- nCPAP, High-flow nasal cannula, Respiratory distress syndrome, NICU, Assiut, Preterm infants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Continuous Positive Airway Pressure | Experimental | Device: Non-invasive respiratory supportPreterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface. |
| High-Flow Nasal Cannula | Active comparator | Device: Non-invasive respiratory supportPreterm infants will receive heated and humidified high-flow nasal cannula therapy. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive respiratory supportNon-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation. | Device | High-Flow Nasal Cannula, Nasal Continuous Positive Airway Pressure |
Primary outcome
Treatment failure within 72 hours
Time frame: 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.
5 secondary outcomes
Need for mechanical ventilation
Time frame: At 72 hours
Need for surfactant therapy
Time frame: At 72 hours
Duration of respiratory support
Time frame: At 28 days
Incidence of nasal trauma
Time frame: At 28 days
Incidence of pneumothorax
Time frame: At 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hekma S Farghaly, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive respiratory support in people with Respiratory Distress Syndrome and Premature Birth, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara S Mahmoud, Resident (+20 11 53798964, Yara.17298705@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure within 72 hours (time frame: At 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.