A NEW SCORING SYSTEM FOR PREDICTION OF PDA
SIMPLE
Can a New Scoring System Predict Hemodynamically Significant PDA Diagnosis and Treatment Requirement for Extremely Preterm Newborns Earlier
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedMay 6, 2020
May 1, 2020
1.9 years
February 12, 2020
May 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Patent Ductus Arteriosus
number of participants who diagnosed for hemodynamically significant PDA and had an elevated score of the newly developed system by us.
7 days
Eligibility Criteria
Infants who born before 28 gestational week and under 1000g of weight will be included.
You may qualify if:
- informed consent obtained from parents
- extremely preterm infants
- infants born before 28 gestational week
You may not qualify if:
- lack of informed consent
- chromosomal abnormality
- cardiovascular abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seda Yilmaz Semerci
Istanbul, 34303, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatologist
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
January 15, 2019
Primary Completion
December 15, 2020
Study Completion
February 15, 2021
Last Updated
May 6, 2020
Record last verified: 2020-05