Noninvasive Ventilation for Respiratory Distress SyndromePhase 4NCT01741129
Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
A Phase 4 study testing Nasal CPAP (SLE) and Nasal IMV (SLE) in people with Noninvasive Ventilation for Respiratory Distress Syndrome, run by Mehmet Yekta at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 2 hours
- Conditions the study is for
- Noninvasive Ventilation for Respiratory Distress Syndrome
- What is being tested?
- Nasal CPAP (SLE) and Nasal IMV (SLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Nov 2013
- Phase
- Phase 4
- 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 Up to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 26-32 weeks
- The criteria for failure were met by at least 1 of the following:
- pH: 7.10 and PaCO2: 70 mm Hg
- Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
- Single episode of apnea that required bag-and-mask ventilation
- PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
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
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, 06230
About this study
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.
- Being tested
- Nasal CPAP (SLE), Nasal IMV (SLE)
- Keywords
- Nasal CPAP, Nasal IMV, Surfactant, Preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CPAP (SLE)Device
Also called SLE 2000, SLE 5000
PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
Nasal IMV (SLE)Device
Also called SLE 2000, SLE 5000
PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
| Study group | Role | What they receive |
|---|---|---|
| Nasal Continuous Positive Airway Pressure (CPAP) | Active comparator | After 2 hours evaluation:
* Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%.
* Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose Receives: Device: Nasal CPAP (SLE) |
| Nasal Intermittent Mandatory Ventilation (IMV) | Active comparator | After 2 hours evaluation:
* Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%.
* Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose Receives: Device: Nasal IMV (SLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
Measured: 3 months
Secondary outcomes (1)
Complications of respiratory support
respiratory insufficiency, pneumothorax
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 posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noninvasive Ventilation for Respiratory Distress SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Yekta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741129
- Sponsor's protocol ID
- ZTB2611
- Status last verified
- Jan 2013
- First submitted
- 26 Nov 2012
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.
PubMed 26553376
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants
- ClinicalTrials.gov ID
- NCT01741129
- Acronym / sponsor ID
- ZTB2611
- Keywords
- Nasal CPAP, Nasal IMV, Surfactant, Preterm infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mehmet YektaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Dec 2012 (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.
The investigators aimed to compare the efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Continuous Positive Airway Pressure (CPAP) | Active comparator | Device: Nasal CPAP (SLE)After 2 hours evaluation: * Infants needed invasive MV (mechanic ventilation) or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%. * Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose |
| Nasal Intermittent Mandatory Ventilation (IMV) | Active comparator | Device: Nasal IMV (SLE)After 2 hours evaluation: * Infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of > 88% to 92%. * Non-invasive surfactant treatment (Curosurf®) 100 mg/kg per dose |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational age 26-32 weeks
- pH: 7.10 and PaCO2: 70 mm Hg
- Recurrent apnea with >3 episodes (Prophylactic caffeine were used in all infants)
- Single episode of apnea that required bag-and-mask ventilation
- PaO2: 50 mmHg with a fraction of inspired oxygen of >0.5.
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 |
|---|---|---|
| Nasal CPAP (SLE)Also: SLE 2000, SLE 5000PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute | Device | Nasal Continuous Positive Airway Pressure (CPAP) |
| Nasal IMV (SLE)Also: SLE 2000, SLE 5000PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute | Device | Nasal Intermittent Mandatory Ventilation (IMV) |
Primary outcome
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants
Time frame: 3 months
If infants needed invasive MV or Required a fraction of inspired oxygen of >40% to maintain the targeted saturation of >88% to 92%, surfactant treatment will give for respiratory distress syndrome (RDS). It means that nasal IMV or CPAP is ineffective.
1 secondary outcome
Complications of respiratory support
Time frame: 3 months
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 10 Mar 2014.
- Derived from this study: PubMed 26553376Oncel MY, Arayici S, Uras N, Alyamac-Dizdar E, Sari FN, Karahan S, Canpolat FE, Oguz SS, Dilmen U. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F323-8. doi: 10.1136/archdischild-2015-308204. Epub 2015 Nov 9.
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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?
A Phase 4 study testing Nasal CPAP (SLE) and Nasal IMV (SLE) in people with Noninvasive Ventilation for Respiratory Distress Syndrome, run by Mehmet Yekta 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 6 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: finished, as of the sponsor's last update on 10 Mar 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (time frame: 3 months). 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 NCT01741129, which also lists 1 linked publication.
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 10 Mar 2014.