PretermNCT07896824
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
A study testing Superimposed sigh breaths and High frequency ventilation in people with Preterm and Respiratory Distress Syndrome in Premature Infant, run by Alexandria University.
Trial summary
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory support at Alexandria University Children's Hospital. Read more about this study
- Who is it for?
- Ages 5 minutes to 6 hours
- Conditions the study is for
- Preterm, Respiratory Distress Syndrome in Premature Infant, Recruitment
- What is being tested?
- Superimposed sigh breaths and High frequency ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 14 Dec 2027
- 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 5 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates will be eligible for inclusion in the study if they meet all of the following criteria:
- Gestational age between less than 37 weeks (best obstetric estimate).
- Age at randomization ≤6 hours of life (preferably ≤2 hours when feasible).
- Requirement of invasive ventilation via endotracheal intubation for respiratory failure, with planned management using high frequency oscillatory ventilation as the primary mode.
- Clinical and/or radiological evidence of diffuse lung disease consistent with respiratory distress syndrome or early diffuse atelectasis, evidenced by at least one of the following:
- Clinical signs of respiratory distress with increasing oxygen requirement despite adequate distending pressure support.
- Lung ultrasound or chest radiograph findings consistent with respiratory distress syndrome or diffuse atelectasis.
- Administration of surfactant therapy as part of standard care.
Who cannot join
None listed.
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: The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants: A Randomized Controlled Trial
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory support at Alexandria University Children's Hospital.
- Conditions
- Preterm, Respiratory Distress Syndrome in Premature Infant, Recruitment, Mechanical Ventilation
- Being tested
- Superimposed sigh breaths, High frequency ventilation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superimposed sigh breathsOther
- Sigh breath rate: incremental increase starting from 5 sighs/ min.
- Inspiratory time: 0.6
- Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP
- Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure.
High frequency ventilationOther
HFOV will be delivered with the following initial settings:
- Frequency: 10-15 Hz, starting at 10 Hz.
- I:E ratio: 1:1.
- Amplitude: adjusted to achieve adequate chest vibration and target PaCO₂.
- MAP: adjusted according to the recruitment protocol and subsequent maintenance pressure strategy.
- Carbon dioxide control will be achieved by adjusting oscillatory amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Group A: High frequency ventilation (HFOV) alone | Active comparator | HFOV will be delivered with the following initial settings:
* Frequency: 10-15 Hz, starting at 10 Hz.
* I:E ratio: 1:1.
* Amplitude: adjusted to achieve adequate chest vibration and target PaCO2.
* Mean airway pressure (MAP): adjusted according to the recruitment protocol and subsequent maintenance pressure strategy.
* Carbon dioxide control will be achieved by adjusting oscillatory amplitude. Receives: Other: High frequency ventilation |
| Group B: High frequency ventilation (HFOV) with Superimposed Sigh Breaths | Active comparator | In addition to HFOV settings identical to Group A, intermittent sigh breaths will be applied using Dräger Babylog® VN600 neonatal ventilator.The sigh settings in the present protocol will be as follows:
* Sigh breath rate: incremental increase starting from 5 sighs/ min.
* Inspiratory time: 0.6
* Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP
* Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure. Receives: Other: Superimposed sigh breaths; Other: High frequency ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation evaluation
To determine whether HFOV with superimposed sigh breaths improves early lung recruitment compared to HFOV alone, as assessed by the oxygenation saturation index (OSI) . OSI is calculated by MAP.FIO2.100/SPaO2.
MAP = Mean Airway Pressure (cmH_2O) FiO₂ = Fraction of Inspired Oxygen (expressed as a decimal, e.g., 0.21 to 1.0) SpO₂ = Pulse oximetry oxygen saturation (%) .
Normal / Mild Respiratory Distress: OSI < 4. Moderate Respiratory Failure: OSI 4.0 to 8.0 Severe Respiratory Failure: OSI > 8.0 to 10.0.
Measured: first 24 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896824
- Sponsor's protocol ID
- 0202435
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896824
- Acronym / sponsor ID
- 0202435
- Conditions
- Preterm, Respiratory Distress Syndrome in Premature Infant, Recruitment, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 14 Dec 2027 (estimated)
- First posted
- 27 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.
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory support at Alexandria University Children's Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: High frequency ventilation (HFOV) alone | Active comparator | Other: High frequency ventilationHFOV will be delivered with the following initial settings: * Frequency: 10-15 Hz, starting at 10 Hz. * I:E ratio: 1:1. * Amplitude: adjusted to achieve adequate chest vibration and target PaCO2. * Mean airway pressure (MAP): adjusted according to the recruitment protocol and subsequent maintenance pressure strategy. * Carbon dioxide control will be achieved by adjusting oscillatory amplitude. |
| Group B: High frequency ventilation (HFOV) with Superimposed Sigh Breaths | Active comparator | Other: Superimposed sigh breaths, Other: High frequency ventilationIn addition to HFOV settings identical to Group A, intermittent sigh breaths will be applied using Dräger Babylog® VN600 neonatal ventilator.The sigh settings in the present protocol will be as follows: * Sigh breath rate: incremental increase starting from 5 sighs/ min. * Inspiratory time: 0.6 * Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP * Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure. |
Who may qualify
- Ages
- 5 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Preterm neonates will be eligible for inclusion in the study if they meet all of the following criteria:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Superimposed sigh breaths* Sigh breath rate: incremental increase starting from 5 sighs/ min. * Inspiratory time: 0.6 * Peak inspiratory pressure (PIP): incremental increase starting from 7 cm.H₂O above the preset MAP * Sigh breaths will be progressively reduced and discontinued once lung recruitment is stable and adequate oxygenation is maintained at the assigned maintenance pressure. | Other | Group B: High frequency ventilation (HFOV) with Superimposed Sigh Breaths |
| High frequency ventilationHFOV will be delivered with the following initial settings: * Frequency: 10-15 Hz, starting at 10 Hz. * I:E ratio: 1:1. * Amplitude: adjusted to achieve adequate chest vibration and target PaCO₂. * MAP: adjusted according to the recruitment protocol and subsequent maintenance pressure strategy. * Carbon dioxide control will be achieved by adjusting oscillatory amplitude. | Other | Group A: High frequency ventilation (HFOV) alone, Group B: High frequency ventilation (HFOV) with Superimposed Sigh Breaths |
Primary outcome
Oxygenation evaluation
Time frame: first 24 hours of life
To determine whether HFOV with superimposed sigh breaths improves early lung recruitment compared to HFOV alone, as assessed by the oxygenation saturation index (OSI) . OSI is calculated by MAP.FIO2.100/SPaO2. MAP = Mean Airway Pressure (cmH_2O) FiO₂ = Fraction of Inspired Oxygen (expressed as a decimal, e.g., 0.21 to 1.0) SpO₂ = Pulse oximetry oxygen saturation (%) . Normal / Mild Respiratory Distress: OSI < 4. Moderate Respiratory Failure: OSI 4.0 to 8.0 Severe Respiratory Failure: OSI > 8.0 to 10.0.
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 27 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Superimposed sigh breaths and High frequency ventilation in people with Preterm and Respiratory Distress Syndrome in Premature Infant, run by Alexandria 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 8 inclusion and 0 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 27 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 Marwa M Farag (01288681788, d.marwa.farag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation evaluation (time frame: first 24 hours of life). 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 27 Oct 2026.