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Status unknownNCT04270240SIMPLEUpdated May 6, 2020

A NEW SCORING SYSTEM FOR PREDICTION OF PDA

An observational study in Patent Ductus Arteriosus and Prematurity; Extreme, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged Up to 15 Days. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 15 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patent Ductus Arteriosus
  • Prematurity; Extreme
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In context

Ductus Arteriosus, Patent

144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 52 observational studies indexed under Ductus Arteriosus, Patent.

Browse Ductus Arteriosus, Patent studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 15 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Infants who born before 28 gestational week and under 1000g of weight will be included.

Inclusion criteria

  • informed consent obtained from parents
  • extremely preterm infants
  • infants born before 28 gestational week

Exclusion criteria

Exclusion Criteria:

  • lack of informed consent
  • chromosomal abnormality
  • cardiovascular abnormality
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04270240
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Merih Cetinkaya (Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Feb 17, 2020
Start date
Jan 15, 2019
Primary completion
Dec 15, 2020 (estimated)
Completion
Feb 15, 2021 (estimated)
Last update
May 6, 2020

Study contacts

Seda Y Semerci
Contact
sedayilmazsemerci@gmail.com
05337180683
Merih Y Cetinkaya
Contact
drmerih@yahoo.com
05337180683

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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