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NCT04270240 Clinical Trial

A NEW SCORING SYSTEM FOR PREDICTION OF PDA

Patent Ductus Arteriosus Clinical Trial

— SIMPLE  

Official title:
Can a New Scoring System Predict Hemodynamically Significant PDA Diagnosis and Treatment Requirement for Extremely Preterm Newborns Earlier

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04270240
Other study ID # MAEEAH6725
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2019
Est. completion date February 15, 2021

Study information
Verified date May 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact Seda Y Semerci
Phone 05337180683
Email sedayilmazsemerci@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 15, 2021
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 15 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Seda Yilmaz Semerci Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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