- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270240
A NEW SCORING SYSTEM FOR PREDICTION OF PDA (SIMPLE)
May 5, 2020 updated by: Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
Can a New Scoring System Predict Hemodynamically Significant PDA Diagnosis and Treatment Requirement for Extremely Preterm Newborns Earlier
Patent ductus arteriosus (PDA) is an important morbidity of that the diagnosis and treatment is controversy in premature infants.
A number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of PDA.
This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.
Study Overview
Status
Unknown
Conditions
Detailed Description
This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Seda Y Semerci
- Phone Number: 05337180683
- Email: sedayilmazsemerci@gmail.com
Study Contact Backup
- Name: Merih Y Cetinkaya
- Phone Number: 05337180683
- Email: drmerih@yahoo.com
Study Locations
-
-
-
Istanbul, Turkey, 34303
- Recruiting
- Seda Yilmaz Semerci
-
Contact:
- Seda Y Semerci
- Phone Number: 05337180683
- Email: sedayilmazsemerci@gmail.com
-
-
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
No older than 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Infants who born before 28 gestational week and under 1000g of weight will be included.
Description
Inclusion Criteria:
- informed consent obtained from parents
- extremely preterm infants
- infants born before 28 gestational week
Exclusion Criteria:
- lack of informed consent
- chromosomal abnormality
- cardiovascular abnormality
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Patent Ductus Arteriosus
Time Frame: 7 days
|
number of participants who diagnosed for hemodynamically significant PDA and had an elevated score of the newly developed system by us.
|
7 days
|
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 (Actual)
January 15, 2019
Primary Completion (Anticipated)
December 15, 2020
Study Completion (Anticipated)
February 15, 2021
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 13, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAEEAH6725
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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