Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

NCT05686343 | Unknown

• 1 other identifier: Ankara University-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.

Conditions

Patent Ductus Arteriosus After Premature Birth

Keywords

Cardiology; Newborn; Diseases; Congenital Heart Defects; Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (4)

• Diameter of PDA

  Measurement the diameter of ductus in mm/weight using echocardiography

  1 year

• Velosity of PDA

  Measurement the velosity of ductus using CW doppler on ecocardiyograpy

  1 year

• Left ventricule expansion

  Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography

  1 year

• Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries

  Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography

  1 year

Study Arms (2)

Treated

Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy

Untreated

Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy

Interventions

Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy DIAGNOSTIC_TEST

Ecocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life

Treated; Untreated

Eligibility Criteria

• Age: 1 Minute - 7 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborns \< 32 weeks

You may qualify if:

• Born at less than 32 weeks newborns

You may not qualify if:

• Congenital heart disease
• Syndromic and/or major congenital anomaly

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Özlem Bayram

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Disease; Heart Defects, Congenital; Ductus Arteriosus, Patent

Interventions

Echocardiography; Ultrasonography, Doppler; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Özlem Bayram

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem Bayram

CONTACT

05058192105; drbayram.ozlem@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 17, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)