Respiratory Distress Syndrome, NewbornNCT04391634
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
A study testing volume guarantee in people with Respiratory Distress Syndrome, Newborn and Respiratory Failure, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants. Read more about this study
- Who is it for?
- Ages 24 to 27 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth
- What is being tested?
- volume guarantee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2017to 30 May 2018
- 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 24 to 27 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infants born <28 weeks of gestation
- respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
- stable condition with pH (acidity of blood)> 7.2 and pCO2 (carbon dioxide partial pressure) <60 mmHg in the blood gas analysis
- no identified genetic syndromes and serious congenital malformations
Who cannot join
- lack of written consent of patients' parents
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Neonatology at Poznań University of Medical Sciences
Poznan, 60-535
About this study
Official title: Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.
Read the detailed description
Prospective, cross-over trial enrolling neonates <28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).
- Being tested
- volume guarantee, pressure-controlled
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Insufficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume guaranteeOther
volume guarantee assist-control mechanical ventilation
pressure-controlledOther
pressure-controlled assist-control mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | Other | Preterm infants on mechanical ventilation Receives: Other: volume guarantee; Other: pressure-controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
StO2
Cerebral oxygenation measured using near-infrared spectroscopy [percent]
Measured: 6 hours
Stroke volume
Stroke volume (SV) monitored with electrical cardiometry [ml]
Measured: 6 hours
Cardiac output
Cardiac output (CO) monitored with electrical cardiometry [L/min]
Measured: 6 hours
Stroke index
Stroke index (SI) monitored with electrical cardiometry [ml/m2]
Measured: 6 hours
Cardiac index
Cardiac index (CI) monitored with electrical cardiometry [L/min/m2]
Measured: 6 hours
Stroke volume variation (SVV)
Stroke volume variation (SVV) monitored with electrical cardiometry [percent]
Measured: 6 hours
Index of contractility
Index of contractility (ICON) monitored with electrical cardiometry
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Aug 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective crossover study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Szczapa, MD, PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391634
- Sponsor's protocol ID
- 388/16
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04391634
- Acronym / sponsor ID
- 388/16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 18 May 2020 (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.
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.
Detailed description
Prospective, cross-over trial enrolling neonates <28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective crossover study
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | Other | Other: volume guarantee, Other: pressure-controlledPreterm infants on mechanical ventilation |
Who may qualify
- Ages
- 24 to 27 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- premature infants born <28 weeks of gestation
- respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
- stable condition with pH (acidity of blood)> 7.2 and pCO2 (carbon dioxide partial pressure) <60 mmHg in the blood gas analysis
- no identified genetic syndromes and serious congenital malformations
Key exclusion criteria (1 listed)
- lack of written consent of patients' parents
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 |
|---|---|---|
| volume guaranteevolume guarantee assist-control mechanical ventilation | Other | Mechanical ventilation |
| pressure-controlledpressure-controlled assist-control mechanical ventilation | Other | Mechanical ventilation |
Primary outcome
StO2
Time frame: 6 hours
Cerebral oxygenation measured using near-infrared spectroscopy [percent]
Stroke volume
Time frame: 6 hours
Stroke volume (SV) monitored with electrical cardiometry [ml]
Cardiac output
Time frame: 6 hours
Cardiac output (CO) monitored with electrical cardiometry [L/min]
Stroke index
Time frame: 6 hours
Stroke index (SI) monitored with electrical cardiometry [ml/m2]
Cardiac index
Time frame: 6 hours
Cardiac index (CI) monitored with electrical cardiometry [L/min/m2]
Stroke volume variation (SVV)
Time frame: 6 hours
Stroke volume variation (SVV) monitored with electrical cardiometry [percent]
Index of contractility
Time frame: 6 hours
Index of contractility (ICON) monitored with electrical cardiometry
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 21 May 2020.
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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.
Tomasz Szczapa, MD, PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing volume guarantee in people with Respiratory Distress Syndrome, Newborn and Respiratory Failure, run by Poznan University of Medical Sciences at 1 site in Poland.
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 4 inclusion and 1 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 21 May 2020. 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 Poland. 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?
StO2 (time frame: 6 hours). The study lists 7 primary outcomes in all. 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 21 May 2020.