- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258517
The Effect of Surfactant Administration on Cerebral Oxygenation
September 1, 2016 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital
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).
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ankara, Turkey, 06100
- Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
<32 week or <1500 g required surfactant treatment for established RDS
Description
Inclusion Criteria:
Clinical diagnosis of respiratory distress syndrome <32 gestational weeks and/or <1500 g birthweight
Exclusion Criteria:
major congenital anomalies complex congenital heart diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
December 7, 2010
First Submitted That Met QC Criteria
December 10, 2010
First Posted (Estimate)
December 13, 2010
Study Record Updates
Last Update Posted (Estimate)
September 5, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIRS-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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