Transient Tachypnea of NewbornPhase 4NCT01499238
Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
A Phase 4 study testing Nasal SIMV and nasal CPAP in people with Transient Tachypnea of Newborn, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung. Read more about this study
- Who is it for?
- Ages 2 hours to 3 days
- Conditions the study is for
- Transient Tachypnea of Newborn
- What is being tested?
- Nasal SIMV and nasal CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2011to Mar 2012
- 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 2 hours to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- >35 gestational week
- wetlung
Who cannot join
- major congenital anomalies
Trial locations and contacts
2 sites in 1 country.
Gamze Demirel, MD contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Ankara
Gamze Demirel, MD, kgamze@hotmail.com
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara
Gamze Demirel, MD, kgamze@hotmail.com
Gamze Demirel, MD
About this study
The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.
Read the detailed description
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.
- Conditions
- Transient Tachypnea of Newborn
- Being tested
- Nasal SIMV, nasal CPAP
- Keywords
- Efficacy, safety, nasal SIMV, nasal CPAP, infants who are >35 gestational week with wet lung
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SIMVDevice
Also called nasal SIMV, SLE 5000
rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%
nasal CPAPDevice
Also called NASAL CPAP, SLE 5000
PEEP: 4-6 mmHg, FİO2: 40%
| Study group | Role | What they receive |
|---|---|---|
| nasal SIMV | Active comparator | rate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40% Receives: Device: Nasal SIMV |
| nasal CPAP | Active comparator | PEEP: 4-6 mmHg, Fio2: 40% Receives: Device: nasal CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age
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 posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea of 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- Principal investigator, Gamze Demirel, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Gamze Demirel, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499238
- Sponsor's protocol ID
- 4
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 26 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
- ClinicalTrials.gov ID
- NCT01499238
- Acronym / sponsor ID
- 4
- Conditions
- Transient Tachypnea of Newborn
- Keywords
- Efficacy, safety, nasal SIMV, nasal CPAP, infants who are >35 gestational week with wet lung
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 26 Dec 2011 (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 SIMV and nasal CPAP in patients with wet lung.
Detailed description
We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are >35 gestational week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal SIMV | Active comparator | Device: Nasal SIMVrate: 30-50/min, PIP: 16, PEEP: 4-6, fİO2: 40% |
| nasal CPAP | Active comparator | Device: nasal CPAPPEEP: 4-6 mmHg, Fio2: 40% |
Who may qualify
- Ages
- 2 hours to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- >35 gestational week
- wetlung
Key exclusion criteria (1 listed)
- major 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 |
|---|---|---|
| Nasal SIMVAlso: nasal SIMV, SLE 5000rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40% | Device | nasal SIMV |
| nasal CPAPAlso: NASAL CPAP, SLE 5000PEEP: 4-6 mmHg, FİO2: 40% | Device | nasal CPAP |
Primary outcome
efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age
Time frame: 3 months
1 secondary outcome
Complications of respiratory support, respiratory insufficiency
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 26 Dec 2011.
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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.
Gamze Demirel, MD contact
Gamze Demirel, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
2 sites 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 SIMV and nasal CPAP in people with Transient Tachypnea of Newborn, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Demirel, MD (kgamze@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age (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 26 Dec 2011.