Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants
NCT ID: NCT01428180
Last Updated: 2016-04-06
Study Results
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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COMPLETED
35 participants
OBSERVATIONAL
2011-04-30
2016-03-31
Brief Summary
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Detailed Description
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* cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
* renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
as measured by near infrared spectroscopy
and to
* stroke volume
* cardiac output
as measured by electrical cardiometry.
The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Indomethacin
Infants treated with Indomethacin
Indomethacin
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Ibuprofen
Infants treated with Ibuprofen
Ibuprofen
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
Ligation
Infants undergoing surgical ligation
Surgical Ligation
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
Interventions
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Indomethacin
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Surgical Ligation
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
Ibuprofen
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
Eligibility Criteria
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Inclusion Criteria
* Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
* parental informed consent
Exclusion Criteria
* Additional major cardiovascular malformations
34 Weeks
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Manuel Schmid
Dr. med.
Principal Investigators
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Manuel B Schmid, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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University Medical Center
Ulm, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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ULMNEONIRS03
Identifier Type: -
Identifier Source: org_study_id
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