Ventilatory Failure(NCPAP)NCT03400670
Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome
A study testing ventilator NCPAP in people with Ventilatory Failure, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation. Read more about this study
- Who is it for?
- Ages 1 hour to 2 hours
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- ventilator NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2017to 5 Feb 2020
- 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 1 hour to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included
Who cannot join
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- Consent not provided or refused
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching
Ankara, 06230
Mehmet Buyuktiryaki, +905054525576, mbuyuktiryaki@yahoo.com
About this study
Official title: Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Read the detailed description
Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
- FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
- Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
- Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
- Severe respiratory distress,
- Pulmonary haemorrhage and cardiopulmonary arrest.
- Conditions
- Ventilatory Failure
- Being tested
- ventilator NCPAP
- Keywords
- NCPAP, Respiratory Distress Syndrome
- Medical subject headings
- Hypoventilation, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilator NCPAPDevice
Also called infant flow driver NCPAP
infants will be randomized into two different NCPAP groups
| Study group | Role | What they receive |
|---|---|---|
| Ventilator NCPAP | Active comparator | neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O Receives: Device: ventilator NCPAP |
| Infant Flow-driver NCPAP | Active comparator | infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow Receives: Device: ventilator NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
noninvasive ventilation failure
need for mechanical ventilation in the first 72 hours of life
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start5 Jan 2017
- Primary completion5 Jan 2020 (estimated)
- Study completion5 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suna Oğuz, Study director, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400670
- Sponsor's protocol ID
- 02082019
- Acronym
- (NCPAP)
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks
- ClinicalTrials.gov ID
- NCT03400670
- Acronym / sponsor ID
- (NCPAP) / 02082019
- Conditions
- Ventilatory Failure
- Keywords
- NCPAP, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 5 Jan 2020 (estimated)
- Study completion
- 5 Feb 2020 (estimated)
- First posted
- 17 Jan 2018 (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.
is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.
Detailed description
Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
- FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
- Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
- Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
- Severe respiratory distress,
- Pulmonary haemorrhage and cardiopulmonary arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator NCPAP | Active comparator | Device: ventilator NCPAPneonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O |
| Infant Flow-driver NCPAP | Active comparator | Device: ventilator NCPAPinfant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow |
Who may qualify
- Ages
- 1 hour to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included
Key exclusion criteria (4 listed)
- Major congenital anomalies
- Presence of cardiovascular instability
- Intubation at admission to the NICU
- Consent not provided or refused
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 |
|---|---|---|
| ventilator NCPAPAlso: infant flow driver NCPAPinfants will be randomized into two different NCPAP groups | Device | Infant Flow-driver NCPAP, Ventilator NCPAP |
Primary outcome
noninvasive ventilation failure
Time frame: 72 hours
need for mechanical ventilation in the first 72 hours of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Ventilatory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
Multiple Myeloma (MM), Breathing Techniques
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.
Suna Oğuz study director
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilator NCPAP in people with Ventilatory Failure, run by Zekai Tahir Burak Women's Health Research and Education Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2019. 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 Mehmet Büyüktiryaki, MD (+905054525576, mbuyuktiryaki@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
noninvasive ventilation failure (time frame: 72 hours). 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 16 Jul 2019.