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Completed

NCT Number: NCT01428180

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

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.

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Key information

Conditions

Prematurity of Fetus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases Patent Ductus Arteriosus

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indomethacin

Drug

3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)

Surgical Ligation

Procedure

In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.

Ibuprofen

Drug

3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg

Primary outcomes

  1. Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus

    Time frame: from 10 minutes before start of infusion until 4 hours after end of transfusion

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Sep 2, 2011
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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