Acute Mechanical Ventilatory FailureRescueHFONCT02752438
Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation
An observational study of Acute Mechanical Ventilatory Failure, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Acute Mechanical Ventilatory Failure
- What is being tested?
- HFOV
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Jul 2017
- How long will I take part?
- 3 Months
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborns with respiratory insufficiency in spite of conventional mechanical ventilation are candidates for the study. When the patient is switched to HFOV for rescue respiratory support, he/she will be followed and registered to online registry system.
Who may be able to join
- patients switched to HFOV in case of unresponse to conventional ventilation
- stay on HFOV for at least 4 h
Who cannot join
- any congenital anomaly
- HFOV duration less then 4 h
Trial locations and contacts
1 site in 1 country.
Omer Erdeve contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Children's Hospital
Ankara, Ankara, 06100
Omer Erdeve, Professor, +905054812151, omererdeve@yahoo.com
About this study
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.
Read the detailed description
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.
The aim of the study is to define the factors that affect the success of HFOV in newborns who do not respond to conventional mechanical ventilation through an online registry among neonatal intensive care units in Turkey.
- Conditions
- Acute Mechanical Ventilatory Failure
- Being tested
- HFOV
- Keywords
- high frequency oscillatory ventilation, rescue, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFOVDevice
HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.
| Study group | Role | What they receive |
|---|---|---|
| Survived | Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation and survived. Receives: Device: HFOV | |
| Death | Patients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation but died. Receives: Device: HFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 3 months
Secondary outcomes (2)
Cut-off gestational age for survival
Measured: 3 months
Cut-off birthweight for survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mechanical Ventilatory FailureStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Etlik Zubeyde Hanim Womens, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Gazi University, Istanbul Medeniyet University, Dr. Behcet Uz Children's Hospital, Manisa Celal Bayar University, Special Metro Hospital, Konya Meram State Hospital, Inonu University
- Responsible party
- Principal investigator, Omer Erdeve, Ankara University
- Investigators
- Omer Erdeve, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752438
- Sponsor's protocol ID
- RescueHFO
- Acronym
- RescueHFO
- Status last verified
- Sep 2016
- First submitted
- 23 Apr 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue High Frequency Oscillatory Ventilation in Newborns Who Do Not Respond to Conventional Ventilation
- ClinicalTrials.gov ID
- NCT02752438
- Acronym / sponsor ID
- RescueHFO / RescueHFO
- Conditions
- Acute Mechanical Ventilatory Failure
- Keywords
- high frequency oscillatory ventilation, rescue, newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Etlik Zubeyde Hanim Womens, Zeynep Kamil Maternity and Pediatric Research and Training Hospital, Gazi University, Istanbul Medeniyet University, Dr. Behcet Uz Children's Hospital, Manisa Celal Bayar University, Special Metro Hospital, Konya Meram State Hospital, Inonu University
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- 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.
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.
Detailed description
Although High Frequency Oscillatory Ventilation (HFOV) has been used in case of unresponsive to conventional mechanical ventilation both in children and newborns, there is no data on its success and the factors that affect its success in the literature.
The aim of the study is to define the factors that affect the success of HFOV in newborns who do not respond to conventional mechanical ventilation through an online registry among neonatal intensive care units in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survived | – | Device: HFOVPatients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation and survived. |
| Death | – | Device: HFOVPatients who are treated with HFOV at least for 4 h in case of unresponse to conventional ventilation but died. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns with respiratory insufficiency in spite of conventional mechanical ventilation are candidates for the study. When the patient is switched to HFOV for rescue respiratory support, he/she will be followed and registered to online registry system.
Key inclusion criteria (2 listed)
- patients switched to HFOV in case of unresponse to conventional ventilation
- stay on HFOV for at least 4 h
Key exclusion criteria (2 listed)
- any congenital anomaly
- HFOV duration less then 4 h
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 |
|---|---|---|
| HFOVHFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume. | Device | Death, Survived |
Primary outcome
Survival
Time frame: 3 months
2 secondary outcomes
Cut-off gestational age for survival
Time frame: 3 months
Cut-off birthweight for survival
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No. No individual data will be shared.
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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.
Omer Erdeve contact
Omer Erdeve principal investigator
Ankara University
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 Acute Mechanical Ventilatory Failure, run by Ankara 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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emel Okulu, Attending (5054812151, emelokulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 3 months). 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 13 Sep 2016.