Community Acquired PneumoniaP-HVNI-CPAPNCT07336121
HVNI vs CPAP in Children With Acute Respiratory Distress
A study testing High Velocity Nasal Insufflation (HVNI) and Nasal Continuous Positive Airway Pressure (Nasal CPAP) in people with Community Acquired Pneumonia and Bronchiolitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Acute breathing problems are a common reason for children to be admitted to the pediatric intensive care unit, and many of these children need breathing support without a breathing tube. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Community Acquired Pneumonia, Bronchiolitis
- What is being tested?
- High Velocity Nasal Insufflation (HVNI) and Nasal Continuous Positive Airway Pressure (Nasal CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 month to 5 years
- Admitted to the Pediatric Intensive Care Unit (PICU)
- Diagnosed with acute respiratory distress
- Failure of low-flow nasal oxygen therapy
- Requiring non-invasive respiratory support
- Informed consent obtained from parent or legal guardian
Who cannot join
- Presence of congenital or acquired cardiac disease
- Neuromuscular disorders
- Chronic lung disease
- History of recurrent wheezing
- History of cardio-respiratory arrest
- Presence of significant comorbid chronic illness
- Contraindication to non-invasive ventilation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Intensive Care Units, Children Hospital, Ain shams university
Cairo, 00002
About this study
Official title: Assessment of Outcome and Tolerability of High Velocity Nasal Insufflation and Continuous Positive Airway Pressure in Children With Acute Respiratory Distress
Acute breathing problems are a common reason for children to be admitted to the pediatric intensive care unit, and many of these children need breathing support without a breathing tube. High-Velocity Nasal Insufflation (HVNI) and nasal Continuous Positive Airway Pressure (nCPAP) are commonly used to help children breathe, but there is limited information comparing how well they work and how comfortable they are for children. This study aims to compare the clinical outcomes and tolerability of HVNI and nCPAP in children aged 1 month to 5 years with acute respiratory distress admitted to the pediatric intensive care unit, using clinical assessment and lung ultrasound findings.
Read the detailed description
Acute respiratory distress represents a major cause of morbidity and mortality in infants and young children and accounts for a significant proportion of pediatric intensive care unit admissions. A considerable number of affected children fail conventional low-flow oxygen therapy and require escalation to non-invasive respiratory support.
High Velocity Nasal Insufflation delivers heated and humidified oxygen at high flow rates through nasal cannulae and may improve oxygenation by washing out nasopharyngeal dead space, reducing inspiratory resistance, and providing a degree of positive end-expiratory pressure. Nasal Continuous Positive Airway Pressure delivers a continuous distending airway pressure with supplemental oxygen, improving lung recruitment, reducing atelectasis, and enhancing ventilation-perfusion matching.
Both modalities are commonly used in pediatric intensive care practice; however, evidence comparing their clinical effectiveness, tolerability, and impact on lung aeration in young children remains inconclusive. Lung ultrasound has emerged as a reliable, non-invasive bedside tool for assessment of lung aeration and disease severity in critically ill children.
This prospective interventional study will enroll 80 children aged 1 month to 5 years admitted to the pediatric intensive care unit with acute respiratory distress who have failed low-flow oxygen therapy. Patients will be randomized into two groups: one group receiving High Velocity Nasal Insufflation and the other receiving nasal Continuous Positive Airway Pressure. All patients will undergo daily clinical assessment and lung ultrasound scoring during their pediatric intensive care unit (PICU) stay. Tolerability will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) pain scale.
The primary outcome is improvement in lung aeration as assessed by lung ultrasound score. Secondary outcomes include assessment of clinical response to therapy based on respiratory rate, oxygen saturation (SpO₂), and need for escalation of respiratory support . The results of this study aim to provide evidence to guide selection of optimal non-invasive respiratory support in children with acute respiratory distress.
- Conditions
- Community Acquired Pneumonia, Bronchiolitis
- Being tested
- High Velocity Nasal Insufflation (HVNI), Nasal Continuous Positive Airway Pressure (Nasal CPAP)
- Keywords
- High -Velocity Nasal Insufflation, Continuous positive Airway Pressure, Pediatric Acute Respiratory Distress, pediatric intensive care unit
- Medical subject headings
- Community-Acquired Pneumonia, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity Nasal Insufflation (HVNI)Device
High Velocity Nasal Insufflation will be delivered using a heated, humidified nasal cannula system to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Therapy will be initiated and adjusted according to clinical condition and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay.
Nasal Continuous Positive Airway Pressure (Nasal CPAP)Device
Nasal Continuous Positive Airway Pressure will be delivered via nasal interface providing continuous positive airway pressure with supplemental oxygen to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Settings will be adjusted according to clinical response and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay.
| Study group | Role | What they receive |
|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Active comparator | Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using High Velocity Nasal Insufflation after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay. Receives: Device: High Velocity Nasal Insufflation (HVNI) |
| Nasal Continuous Positive Airway Pressure (Nasal CPAP) | Active comparator | Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using nasal Continuous Positive Airway Pressure after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay. Receives: Device: Nasal Continuous Positive Airway Pressure (Nasal CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in lung aeration assessed by lung ultrasound score
To compare the effectiveness of High Velocity Nasal Insufflation versus Nasal Continuous Positive Airway Pressure in improving lung aeration in children with acute respiratory distress, assessed by daily lung ultrasound score during PICU stay.
The LUS ranges from 0 to 36, where higher scores indicate worse lung aeration and lower scores indicate improvement.
Measured: At Baseline, pre procedural , 48 hours .
Secondary outcomes (1)
Clinical improvement of respiratory distress assessed by Modified Respiratory Distress Score
Clinical improvement assessed using a Modified Respiratory Distress Score(MRDS), which incorporates respiratory rate (breaths/min), oxygen saturation measured by pulse oximetry (SpO₂, %), and fraction of inspired oxygen (FiO₂, %).
The MRDS ranges from 0 to 12, where higher scores indicate more severe respiratory distress and lower scores indicate clinical improvement.
Measured: Baseline and 48 hours after initiation of respiratory support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start9 Jan 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek A. Abdelgawad, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336121
- Sponsor's protocol ID
- FMASU MD 11/2023
- Other IDs
- FMASU MD 11 /2023
- Acronym
- P-HVNI-CPAP
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Publications
Liu C, Cheng WY, Li JS, Tang T, Tan PL, Yang L. High-Flow Nasal Cannula vs. Continuous Positive Airway Pressure Therapy for the Treatment of Children <2 Years With Mild to Moderate Respiratory Failure Due to Pneumonia. Front Pediatr. 2020 Nov 13;8:590906. doi: 10.3389/fped.2020.590906. eCollection 2020.
PubMed 33304868
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Outcome and Tolerability of High Velocity Nasal Insufflation and Continuous Positive Airway Pressure in Children With Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT07336121
- Acronym / sponsor ID
- P-HVNI-CPAP / FMASU MD 11/2023
- Conditions
- Community Acquired Pneumonia, Bronchiolitis
- Keywords
- High -Velocity Nasal Insufflation, Continuous positive Airway Pressure, Pediatric Acute Respiratory Distress, pediatric intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Jan 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.
Acute breathing problems are a common reason for children to be admitted to the pediatric intensive care unit, and many of these children need breathing support without a breathing tube. High-Velocity Nasal Insufflation (HVNI) and nasal Continuous Positive Airway Pressure (nCPAP) are commonly used to help children breathe, but there is limited information comparing how well they work and how comfortable they are for children. This study aims to compare the clinical outcomes and tolerability of HVNI and nCPAP in children aged 1 month to 5 years with acute respiratory distress admitted to the pediatric intensive care unit, using clinical assessment and lung ultrasound findings.
Detailed description
Acute respiratory distress represents a major cause of morbidity and mortality in infants and young children and accounts for a significant proportion of pediatric intensive care unit admissions. A considerable number of affected children fail conventional low-flow oxygen therapy and require escalation to non-invasive respiratory support.
High Velocity Nasal Insufflation delivers heated and humidified oxygen at high flow rates through nasal cannulae and may improve oxygenation by washing out nasopharyngeal dead space, reducing inspiratory resistance, and providing a degree of positive end-expiratory pressure. Nasal Continuous Positive Airway Pressure delivers a continuous distending airway pressure with supplemental oxygen, improving lung recruitment, reducing atelectasis, and enhancing ventilation-perfusion matching.
Both modalities are commonly used in pediatric intensive care practice; however, evidence comparing their clinical effectiveness, tolerability, and impact on lung aeration in young children remains inconclusive. Lung ultrasound has emerged as a reliable, non-invasive bedside tool for assessment of lung aeration and disease severity in critically ill children.
This prospective interventional study will enroll 80 children aged 1 month to 5 years admitted to the pediatric intensive care unit with acute respiratory distress who have failed low-flow oxygen therapy. Patients will be randomized into two groups: one group receiving High Velocity Nasal Insufflation and the other receiving nasal Continuous Positive Airway Pressure. All patients will undergo daily clinical assessment and lung ultrasound scoring during their pediatric intensive care unit (PICU) stay. Tolerability will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) pain scale.
The primary outcome is improvement in lung aeration as assessed by lung ultrasound score. Secondary outcomes include assessment of clinical response to therapy based on respiratory rate, oxygen saturation (SpO₂), and need for escalation of respiratory support . The results of this study aim to provide evidence to guide selection of optimal non-invasive respiratory support in children with acute respiratory distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Velocity Nasal Insufflation (HVNI) | Active comparator | Device: High Velocity Nasal Insufflation (HVNI)Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using High Velocity Nasal Insufflation after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay. |
| Nasal Continuous Positive Airway Pressure (Nasal CPAP) | Active comparator | Device: Nasal Continuous Positive Airway Pressure (Nasal CPAP)Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using nasal Continuous Positive Airway Pressure after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 1 month to 5 years
- Admitted to the Pediatric Intensive Care Unit (PICU)
- Diagnosed with acute respiratory distress
- Failure of low-flow nasal oxygen therapy
- Requiring non-invasive respiratory support
Key exclusion criteria (7 listed)
- Presence of congenital or acquired cardiac disease
- Neuromuscular disorders
- Chronic lung disease
- History of recurrent wheezing
- History of cardio-respiratory arrest
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 |
|---|---|---|
| High Velocity Nasal Insufflation (HVNI)High Velocity Nasal Insufflation will be delivered using a heated, humidified nasal cannula system to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Therapy will be initiated and adjusted according to clinical condition and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay. | Device | High Velocity Nasal Insufflation (HVNI) |
| Nasal Continuous Positive Airway Pressure (Nasal CPAP)Nasal Continuous Positive Airway Pressure will be delivered via nasal interface providing continuous positive airway pressure with supplemental oxygen to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Settings will be adjusted according to clinical response and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay. | Device | Nasal Continuous Positive Airway Pressure (Nasal CPAP) |
Primary outcome
Improvement in lung aeration assessed by lung ultrasound score
Time frame: At Baseline, pre procedural , 48 hours .
To compare the effectiveness of High Velocity Nasal Insufflation versus Nasal Continuous Positive Airway Pressure in improving lung aeration in children with acute respiratory distress, assessed by daily lung ultrasound score during PICU stay. The LUS ranges from 0 to 36, where higher scores indicate worse lung aeration and lower scores indicate improvement.
1 secondary outcome
Clinical improvement of respiratory distress assessed by Modified Respiratory Distress Score
Time frame: Baseline and 48 hours after initiation of respiratory support
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 33304868Liu C, Cheng WY, Li JS, Tang T, Tan PL, Yang L. High-Flow Nasal Cannula vs. Continuous Positive Airway Pressure Therapy for the Treatment of Children <2 Years With Mild to Moderate Respiratory Failure Due to Pneumonia. Front Pediatr. 2020 Nov 13;8:590906. doi: 10.3389/fped.2020.590906. eCollection 2020.
- High flow nasal cannula therapy versus continuous positive airway pressure and nasal positive pressure ventilation in infants with severe bronchiolitis: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share
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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. This study is not recruiting at the moment.
Tarek A. Abdelgawad, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Nasal Insufflation (HVNI) and Nasal Continuous Positive Airway Pressure (Nasal CPAP) in people with Community Acquired Pneumonia and Bronchiolitis, run by Ain Shams University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in lung aeration assessed by lung ultrasound score (time frame: At Baseline, pre procedural , 48 hours .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336121, which also lists 1 linked publication.
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 27 Jan 2026.