Clinical Trials Logo
  1. Home
  2. Patent Ductus Arteriosus
  3. NCT04270240
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04986839 - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial Phase 2/Phase 3
Recruiting NCT03648437 - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus Phase 1
Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Completed NCT00217191 - Ibuprofen and Renal Function in Premature Infants Phase 4
Not yet recruiting NCT02894970 - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.