Respiratory Distress SyndromeNCT01258517
The Effect of Surfactant Administration on Cerebral Oxygenation
An observational study of Respiratory Distress Syndrome and Prematurity, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS). Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Prematurity
- What is being tested?
- near infrared spectroscopy (INVOS 5100)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2010to Dec 2018
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: <32 week or <1500 g required surfactant treatment for established RDS
Who may be able to join
- Clinical diagnosis of respiratory distress syndrome <32 gestational weeks and/or <1500 g birthweight
Who cannot join
- major congenital anomalies complex congenital heart diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive Care Unit
Ankara, 06100
About this study
Official title: The Effect of the Type and the Method of Surfactant Administration on Oxygenation in Preterm Infants: a Near Infrared Spectroscopy Study
The purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).
- Conditions
- Respiratory Distress Syndrome, Prematurity
- Being tested
- near infrared spectroscopy (INVOS 5100)
- Keywords
- RDS, surfactant, cerebral oxygenation, near infrared spectroscopy
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopy (INVOS 5100)Device
monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration
| Study group | Role | What they receive |
|---|---|---|
| group 1, group 2, group 3, group 4 | administration of beractant with single lumen ET tube administration of poractant with single lumen ET tube administration of beractant with double lumen ET tube administration of poractant with double lumen ET tube Receives: Device: near infrared spectroscopy (INVOS 5100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the optimal and the most safe surfactant administration technique with regard to cerebral oxygenation as measured by near infrared spectroscopy in low birth weigh infants
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: principle investigator moved to an another hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258517
- Sponsor's protocol ID
- NIRS-018
- Status last verified
- Nov 2010
- First submitted
- 7 Dec 2010
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Type and the Method of Surfactant Administration on Oxygenation in Preterm Infants: a Near Infrared Spectroscopy Study
- ClinicalTrials.gov ID
- NCT01258517
- Acronym / sponsor ID
- NIRS-018
- Conditions
- Respiratory Distress Syndrome, Prematurity
- Keywords
- RDS, surfactant, cerebral oxygenation, near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: principle investigator moved to an another hospital
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Dec 2010 (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 purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1, group 2, group 3, group 4 | – | Device: near infrared spectroscopy (INVOS 5100)administration of beractant with single lumen ET tube administration of poractant with single lumen ET tube administration of beractant with double lumen ET tube administration of poractant with double lumen ET tube |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- <32 week or <1500 g required surfactant treatment for established RDS
Key inclusion criteria (1 listed)
- Clinical diagnosis of respiratory distress syndrome <32 gestational weeks and/or <1500 g birthweight
Key exclusion criteria (1 listed)
- major congenital anomalies complex congenital heart diseases
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 |
|---|---|---|
| near infrared spectroscopy (INVOS 5100)monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration | Device | group 1, group 2, group 3, group 4 |
Primary outcome
to determine the optimal and the most safe surfactant administration technique with regard to cerebral oxygenation as measured by near infrared spectroscopy in low birth weigh infants
Time frame: up to 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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 Respiratory Distress Syndrome and Prematurity, 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 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: paused, as of the sponsor's last update on 5 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?
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?
to determine the optimal and the most safe surfactant administration technique with regard to cerebral oxygenation as measured by near infrared spectroscopy in low birth weigh infants (time frame: up to 36 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 5 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.