Newborn MorbidityNCT04191239
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
An observational study of Newborn Morbidity and Respiratory Failure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia
- What is being tested?
- GE ventilator with two different modes
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Observational
- 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 day to 3 months
- All sexes
- Child
Study population: All preterms under 32 weeks and between 800-1200 grams, intubated and ventilated in neonatal intensvie care unit
Who may be able to join
- Need for mechanical ventilation
- 800-1200 grams of birthweight
- Surfactant received
- under 32 weeks of gestational age
Who cannot join
- No need to intubation Congenital anomalies
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Being tested
- GE ventilator with two different modes
- Medical subject headings
- Respiratory Insufficiency, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE ventilator with two different modesDevice
GE ventilator with two different modes
| Study group | Role | What they receive |
|---|---|---|
| PRVC | Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation Receives: Device: GE ventilator with two different modes | |
| Bilevel VG | Preterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation Receives: Device: GE ventilator with two different modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Duration of mechanical ventilation
Measured: 8 weeks
Secondary outcomes (1)
Oxygen dependency
Need for supplemantal oxygen
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191239
- Sponsor's protocol ID
- 2019512-2
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control
- ClinicalTrials.gov ID
- NCT04191239
- Acronym / sponsor ID
- 2019512-2
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 9 Dec 2019 (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.
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRVC | – | Device: GE ventilator with two different modesPreterm infants with need of mechanical ventilation will receive PRVC mode until extubation |
| Bilevel VG | – | Device: GE ventilator with two different modesPreterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Age groups
- Child
- Study population
- All preterms under 32 weeks and between 800-1200 grams, intubated and ventilated in neonatal intensvie care unit
Key inclusion criteria (4 listed)
- Need for mechanical ventilation
- 800-1200 grams of birthweight
- Surfactant received
- under 32 weeks of gestational age
Key exclusion criteria (2 listed)
- No need to intubation Congenital anomalies
- -
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 |
|---|---|---|
| GE ventilator with two different modesGE ventilator with two different modes | Device | Bilevel VG, PRVC |
Primary outcome
Intubation time
Time frame: 8 weeks
Duration of mechanical ventilation
1 secondary outcome
Oxygen dependency
Time frame: 8 weeks
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 9 Aug 2021.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Newborn Morbidity and Respiratory Failure, run by Ankara City Hospital Bilkent 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 4 inclusion and 2 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 9 Aug 2021. 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?
Intubation time (time frame: 8 weeks). 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 9 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.