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

Completed

• Conditions: Prematurity of Fetus; Patent Ductus Arteriosus
• Interventions: Procedure: Surgical Ligation; Drug: Ibuprofen; Drug: Indomethacin

• Registration Number: NCT01428180
• Lead Sponsor: University of Ulm

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Primary Completion: 2012-10
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ligation	Surgical Ligation	Infants undergoing surgical ligation
Ibuprofen	Ibuprofen	Infants treated with Ibuprofen
Indomethacin	Indomethacin	Infants treated with Indomethacin

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Ulm, Baden-Württemberg, Germany