Persistent Pulmonary HypertensionNCT07850908
Pressure Regulated Volume Control Ventilation in Neonates Persistent Pulmonary Hypertension
A study of Persistent Pulmonary Hypertension and Mechanical Ventilation Strategies, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies, Neonatal Intensive Care Unit (NICU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2026to 28 Feb 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 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with confirmed diagnosis of persistent pulmonary hypertension of the newborn (echocardiographic evidence of elevated pulmonary artery pressures) who needed Mechanical ventilation .
- Gestational age ≥ 34 weeks.
- Requiring mechanical ventilation within the first week of life.
Who cannot join
- Neonates with major congenital heart disease (except patent ductus arteriosus or patent foramen ovale).
- Severe congenital anomalies (e.g., diaphragmatic hernia, chromosomal abnormalities).
- Prior use of high-frequency oscillatory ventilation before enrollment.
- Parental refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pressure Regulated Volume Control Ventilation Mode in Neonates With Persistent Pulmonary Hypertension
This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
Read the detailed description
Persistent pulmonary hypertension of the newborn is a serious and life-threatening condition characterized by sustained elevation of pulmonary vascular resistance leading to right-to-left shunting and severe hypoxemia in neonates Effective management often requires advanced ventilatory support to optimize oxygenation and reduce pulmonary vascular pressures.
Mechanical ventilation strategies in neonates with PPHN aim to achieve adequate gas exchange while minimizing ventilator-induced lung injury . Conventional modes such as pressure-controlled ventilation and volume-controlled ventilation have limitations: Pressure-controlled ventilation provides consistent airway pressures but variable tidal volumes, while volume-controlled ventilation delivers stable tidal volumes but may generate injurious peak inspiratory pressures particularly in non-homogeneous lungs.
Pressure-Regulated Volume Control is a dual-control ventilation mode that combines the advantages of Pressure-controlled ventilation and Volume Control ventilation by adjusting inspiratory pressures to achieve a set target tidal volume while maintaining the lowest possible airway pressures . This adaptive mode potentially enhances patient-ventilator synchrony, reduces barotrauma and volutrauma and optimizes oxygen delivery in fragile neonatal lungs This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
- Conditions
- Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies, Neonatal Intensive Care Unit (NICU), Ventilation
- Being tested
- Pressure-Controlled Ventilation, Group II (Pressure-Regulated Volume Control)
- Keywords
- Neonatal Intensive Care Unit, Pressure-Regulated Volume Control, ventilation, Mechanical ventilation strategies
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure-Controlled VentilationDevice
Group I (Pressure-Controlled Ventilation) will be ventilated using Pressure-Controlled Ventilation mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters.
Group II (Pressure-Regulated Volume Control)Device
Group II (PRVC) will be ventilated using Pressure-Regulated Volume Control (PRVC) mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures.
| Study group | Role | What they receive |
|---|---|---|
| Group I (pressure-controlled ventilation) | Experimental | Group I (pressure-controlled ventilation) will be ventilated using Pressure-Controlled Ventilation (PCV) mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters. Receives: Device: Pressure-Controlled Ventilation |
| Group II (Pressure-Regulated Volume Control ) | Experimental | Group II (Pressure-Regulated Volume Control ) will be ventilated using Pressure-Regulated Volume Control mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures. Receives: Device: Group II (Pressure-Regulated Volume Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of oxygenation index.
The oxygenation index was calculated on each intubated patient for days 1, 3 and 7 using the following formula: mean airway pressure × FIO2/PaO2.
Measured: at day 5 of ventilation
Secondary outcomes (1)
Change in Mean Airway Pressure
Measured: At 6, 12, 24, and 48 hours after initiation of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start28 Feb 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fathy Shalaan, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850908
- Sponsor's protocol ID
- 36264MS10101051/ 1/26
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be provided if it needed
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Regulated Volume Control Ventilation Mode in Neonates With Persistent Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07850908
- Acronym / sponsor ID
- 36264MS10101051/ 1/26
- Conditions
- Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies, Neonatal Intensive Care Unit (NICU), Ventilation
- Keywords
- Neonatal Intensive Care Unit, Pressure-Regulated Volume Control, ventilation, Mechanical ventilation strategies
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Sep 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 study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
Detailed description
Persistent pulmonary hypertension of the newborn is a serious and life-threatening condition characterized by sustained elevation of pulmonary vascular resistance leading to right-to-left shunting and severe hypoxemia in neonates Effective management often requires advanced ventilatory support to optimize oxygenation and reduce pulmonary vascular pressures.
Mechanical ventilation strategies in neonates with PPHN aim to achieve adequate gas exchange while minimizing ventilator-induced lung injury . Conventional modes such as pressure-controlled ventilation and volume-controlled ventilation have limitations: Pressure-controlled ventilation provides consistent airway pressures but variable tidal volumes, while volume-controlled ventilation delivers stable tidal volumes but may generate injurious peak inspiratory pressures particularly in non-homogeneous lungs.
Pressure-Regulated Volume Control is a dual-control ventilation mode that combines the advantages of Pressure-controlled ventilation and Volume Control ventilation by adjusting inspiratory pressures to achieve a set target tidal volume while maintaining the lowest possible airway pressures . This adaptive mode potentially enhances patient-ventilator synchrony, reduces barotrauma and volutrauma and optimizes oxygen delivery in fragile neonatal lungs This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (pressure-controlled ventilation) | Experimental | Device: Pressure-Controlled VentilationGroup I (pressure-controlled ventilation) will be ventilated using Pressure-Controlled Ventilation (PCV) mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters. |
| Group II (Pressure-Regulated Volume Control ) | Experimental | Device: Group II (Pressure-Regulated Volume Control)Group II (Pressure-Regulated Volume Control ) will be ventilated using Pressure-Regulated Volume Control mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures. |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates with confirmed diagnosis of persistent pulmonary hypertension of the newborn (echocardiographic evidence of elevated pulmonary artery pressures) who needed Mechanical ventilation .
- Gestational age ≥ 34 weeks.
- Requiring mechanical ventilation within the first week of life.
Key exclusion criteria (4 listed)
- Neonates with major congenital heart disease (except patent ductus arteriosus or patent foramen ovale).
- Severe congenital anomalies (e.g., diaphragmatic hernia, chromosomal abnormalities).
- Prior use of high-frequency oscillatory ventilation before enrollment.
- Parental refusal to participate.
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 |
|---|---|---|
| Pressure-Controlled VentilationGroup I (Pressure-Controlled Ventilation) will be ventilated using Pressure-Controlled Ventilation mode, in which the inspiratory pressure is manually adjusted to achieve adequate tidal volume and optimal gas exchange while maintaining target oxygenation and ventilation parameters. | Device | Group I (pressure-controlled ventilation) |
| Group II (Pressure-Regulated Volume Control)Group II (PRVC) will be ventilated using Pressure-Regulated Volume Control (PRVC) mode as the primary ventilation strategy. The target tidal volume will be set at 6-8 ml/kg, and the ventilator will automatically regulate inspiratory pressure to achieve this preset tidal volume while minimizing peak airway pressures. | Device | Group II (Pressure-Regulated Volume Control ) |
Primary outcome
Improvement of oxygenation index.
Time frame: at day 5 of ventilation
The oxygenation index was calculated on each intubated patient for days 1, 3 and 7 using the following formula: mean airway pressure × FIO2/PaO2.
1 secondary outcome
Change in Mean Airway Pressure
Time frame: At 6, 12, 24, and 48 hours after initiation of ventilation
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. It will be provided if it needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Persistent Pulmonary Hypertension and Mechanical Ventilation Strategies, run by Tanta 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 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?
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?
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 of oxygenation index. (time frame: at day 5 of ventilation). 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 30 Sep 2026.