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

This study is currently recruiting participants.
Verified July 2012 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm
ClinicalTrials.gov Identifier:
NCT01428180
First received: August 31, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prematurity of Fetus
Patent Ductus Arteriosus
 Drug: Indomethacin
Procedure: Surgical Ligation
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infants with hemodynamically relevant patent ductus arteriosus 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.

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.

  Eligibility

Ages Eligible for Study:   up to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm neonates with patent ductus arteriosus treated in our hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428180

Contacts
Contact: Manuel B Schmid, Dr. med. +49 731 500 ext 57218 manuel.schmid@uniklinik-ulm.de

Locations
Germany
University Medical Center Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Manuel B Schmid, Dr. med.     +49 731 500 ext 57218     manuel.schmid@uni-ulm.de    
Principal Investigator: Manuel B Schmid, Dr. med.            
Sub-Investigator: Hans W Fuchs, Dr. med.            
Sub-Investigator: Reinhard J Hopfner, Dr. med.            
Sub-Investigator: Helmut D Hummler, Dr. med.            
Sub-Investigator: Elvira Stoll            
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
  More Information

No publications provided

Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01428180     History of Changes
Other Study ID Numbers: ULMNEONIRS03
Study First Received: August 31, 2011
Last Updated: July 24, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
preterm neonates
hemodynamically relevant patent ductus arteriosus

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013