Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Detailed Description
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In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to 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.

Official Title
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Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates

Conditions
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Prematurity of Fetus, Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: Indomethacin
* Procedure: Surgical Ligation
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn infant below 34 weeks postmenstrual age at the time of birth Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist) parental informed consent Exclusion Criteria: Patent ductus arteriosus as part of malformation syndrome Additional major cardiovascular malformations

Ages Eligible for Study
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Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indomethacin<br>Infants treated with Indomethacin | Drug: Indomethacin<br>* 3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)<br>|
| Ibuprofen<br>Infants treated with Ibuprofen | Drug: Ibuprofen<br>* 3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg<br>|
| Ligation<br>Infants undergoing surgical ligation | Procedure: Surgical Ligation<br>* In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus |  | from 10 minutes before start of infusion until 4 hours after end of transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm neonates, hemodynamically relevant patent ductus arteriosus