Respiratory Distress in NeonatesNCT07465237
Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation
A study testing Pressure Rise Time Adjustment in people with Respiratory Distress in Neonates and Mechanical Ventilation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates. Pressure rise time is an adjustable parameter that influences how quickly inspiratory pressure reaches the target level during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Respiratory Distress in Neonates, Mechanical Ventilation
- What is being tested?
- Pressure Rise Time Adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 Jul 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates receiving volume-guaranteed mechanical ventilation
- Patients monitored in the neonatal intensive care unit
- Clinically stable neonates undergoing ventilator setting adjustments
Who cannot join
- Major congenital anomalies affecting respiratory function
- Hemodynamic instability
- Patients requiring immediate ventilator mode changes or emergency interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Medicine
Ankara, 06100
About this study
Official title: Short-term Physiological Effects of Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation
This study investigates the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates. Pressure rise time is an adjustable parameter that influences how quickly inspiratory pressure reaches the target level during mechanical ventilation.
In this study, different pressure rise time settings will be applied during volume-guaranteed ventilation, and their effects on respiratory parameters, gas exchange, and patient-ventilator interaction will be evaluated. The aim is to determine whether modulation of pressure rise time has measurable short-term physiological effects in ventilated neonates and to identify optimal ventilator settings that may improve respiratory support.
Read the detailed description
Mechanical ventilation is frequently required in neonatal intensive care units, particularly for preterm infants with respiratory distress. Volume-guaranteed ventilation is commonly used because it helps maintain stable tidal volumes while minimizing ventilator-induced lung injury.
Pressure rise time is a ventilator parameter that determines how quickly inspiratory pressure reaches the target level at the beginning of each breath. Alterations in pressure rise time may influence inspiratory flow characteristics, patient-ventilator synchrony, and overall respiratory mechanics. However, limited data are available regarding the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates.
The objective of this study is to evaluate the short-term physiological responses to different pressure rise time settings during volume-guaranteed ventilation in neonates receiving respiratory support in the neonatal intensive care unit. Respiratory parameters, ventilator measurements, and gas exchange indicators will be monitored while sequentially applying different pressure rise time settings.
The findings of this study may contribute to a better understanding of ventilator parameter optimization in neonatal respiratory care and may help guide clinicians in selecting ventilator settings that improve patient-ventilator interaction and respiratory stability.
- Being tested
- Pressure Rise Time Adjustment
- Keywords
- Neonatal ventilation, Volume-guaranteed ventilation, Pressure rise time, Mechanical ventilation, Neonate, Ventilator settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Rise Time AdjustmentDevice
Adjustment of pressure rise time settings during volume-guaranteed neonatal ventilation to evaluate short-term physiological responses.
| Study group | Role | What they receive |
|---|---|---|
| Pressure Rise Time Modulation | Experimental | Neonates receiving volume-guaranteed ventilation in whom different pressure rise time settings are sequentially applied to evaluate short-term physiological effects. Receives: Device: Pressure Rise Time Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak inspiratory pressure
Assessment of changes in peak inspiratory pressure following different pressure rise time settings.
Measured: Immediately after pressure rise time adjustment during the study procedure
Secondary outcomes (1)
Change in mean airway pressure
Evaluation of changes in mean airway pressure associated with different pressure rise time settings during volume-guaranteed ventilation.
Measured: Immediately after ventilator adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Jul 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress in NeonatesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Different pressure rise time settings will be sequentially applied during volume-guaranteed ventilation in the same neonates, and short-term physiological responses will be evaluated.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferid Aliyev, Hacettepe University
- Investigators
- Ferid Aliyev, MD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465237
- Sponsor's protocol ID
- KA-21062
- Other IDs
- KA-21062
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.
Publications
Aliyev F. Pressure rise time modulation during neonatal ventilation: study protocol. Hacettepe University Faculty of Medicine. 2026.
Aliyev F, Yigit S, Yucel E, Tandircioglu UA. Short-term physiological effects of pressure rise time modulation during volume-guaranteed neonatal ventilation. Sci Rep. 2026 Mar 30;16(1):10620. doi: 10.1038/s41598-026-44486-5.
PubMed 41912661
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Physiological Effects of Pressure Rise Time Modulation During Volume-Guaranteed Neonatal Ventilation
- ClinicalTrials.gov ID
- NCT07465237
- Acronym / sponsor ID
- KA-21062
- Keywords
- Neonatal ventilation, Volume-guaranteed ventilation, Pressure rise time, Mechanical ventilation, Neonate, Ventilator settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 11 Mar 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 investigates the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates. Pressure rise time is an adjustable parameter that influences how quickly inspiratory pressure reaches the target level during mechanical ventilation.
In this study, different pressure rise time settings will be applied during volume-guaranteed ventilation, and their effects on respiratory parameters, gas exchange, and patient-ventilator interaction will be evaluated. The aim is to determine whether modulation of pressure rise time has measurable short-term physiological effects in ventilated neonates and to identify optimal ventilator settings that may improve respiratory support.
Detailed description
Mechanical ventilation is frequently required in neonatal intensive care units, particularly for preterm infants with respiratory distress. Volume-guaranteed ventilation is commonly used because it helps maintain stable tidal volumes while minimizing ventilator-induced lung injury.
Pressure rise time is a ventilator parameter that determines how quickly inspiratory pressure reaches the target level at the beginning of each breath. Alterations in pressure rise time may influence inspiratory flow characteristics, patient-ventilator synchrony, and overall respiratory mechanics. However, limited data are available regarding the short-term physiological effects of pressure rise time modulation during volume-guaranteed ventilation in neonates.
The objective of this study is to evaluate the short-term physiological responses to different pressure rise time settings during volume-guaranteed ventilation in neonates receiving respiratory support in the neonatal intensive care unit. Respiratory parameters, ventilator measurements, and gas exchange indicators will be monitored while sequentially applying different pressure rise time settings.
The findings of this study may contribute to a better understanding of ventilator parameter optimization in neonatal respiratory care and may help guide clinicians in selecting ventilator settings that improve patient-ventilator interaction and respiratory stability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Different pressure rise time settings will be sequentially applied during volume-guaranteed ventilation in the same neonates, and short-term physiological responses will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Pressure Rise Time Modulation | Experimental | Device: Pressure Rise Time AdjustmentNeonates receiving volume-guaranteed ventilation in whom different pressure rise time settings are sequentially applied to evaluate short-term physiological effects. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates receiving volume-guaranteed mechanical ventilation
- Patients monitored in the neonatal intensive care unit
- Clinically stable neonates undergoing ventilator setting adjustments
Key exclusion criteria (3 listed)
- Major congenital anomalies affecting respiratory function
- Hemodynamic instability
- Patients requiring immediate ventilator mode changes or emergency interventions
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 Rise Time AdjustmentAdjustment of pressure rise time settings during volume-guaranteed neonatal ventilation to evaluate short-term physiological responses. | Device | Pressure Rise Time Modulation |
Primary outcome
Change in peak inspiratory pressure
Time frame: Immediately after pressure rise time adjustment during the study procedure
Assessment of changes in peak inspiratory pressure following different pressure rise time settings.
1 secondary outcome
Change in mean airway pressure
Time frame: Immediately after ventilator adjustment
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 11 Mar 2026.
- BackgroundAliyev F. Pressure rise time modulation during neonatal ventilation: study protocol. Hacettepe University Faculty of Medicine. 2026.
- Derived from this study: PubMed 41912661Aliyev F, Yigit S, Yucel E, Tandircioglu UA. Short-term physiological effects of pressure rise time modulation during volume-guaranteed neonatal ventilation. Sci Rep. 2026 Mar 30;16(1):10620. doi: 10.1038/s41598-026-44486-5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and patient confidentiality considerations.
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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.
Ferid Aliyev, MD principal investigator
Hacettepe 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 Pressure Rise Time Adjustment in people with Respiratory Distress in Neonates and Mechanical Ventilation, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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 11 Mar 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 Turkey (Türkiye). 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?
Change in peak inspiratory pressure (time frame: Immediately after pressure rise time adjustment during the study procedure). 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 NCT07465237, which also lists 2 linked publications.
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 11 Mar 2026.