NCT01428180

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 34 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity of Fetus
• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Indomethacin	3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
PROCEDURE	Surgical Ligation	In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
DRUG	Ibuprofen	3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-10-01
• Completion: 2016-03-01
• First posted: 2011-09-02
• Last updated: 2016-04-06

Locations

1 site across 1 country: Germany