Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

NCT ID: NCT05686343

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Patent Ductus Arteriosus After Premature Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated

Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy

Intervention Type 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

Untreated

Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy

Intervention Type 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

Interventions

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Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Born at less than 32 weeks newborns

Exclusion Criteria

* Congenital heart disease
* Syndromic and/or major congenital anomaly
Minimum Eligible Age

1 Minute

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Özlem Bayram

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Bayram

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Özlem Bayram

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Özlem Bayram

Role: CONTACT

05058192105

Facility Contacts

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Özlem Bayram

Role: primary

05058192105

Other Identifiers

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Ankara University-001

Identifier Type: -

Identifier Source: org_study_id

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