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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm
ClinicalTrials.gov Identifier:
NCT01428180
First received: August 31, 2011
Last updated: April 5, 2016
Last verified: April 2016
  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
Drug: Ibuprofen
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:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2011
Study Completion Date: March 2016
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Indomethacin
Infants treated with Indomethacin
Drug: Indomethacin
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
Ibuprofen
Infants treated with Ibuprofen
Drug: Ibuprofen
3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
Ligation
Infants undergoing surgical ligation
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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
University Medical Center
Ulm, Baden-Württemberg, Germany, 89075
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
  More Information

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: April 5, 2016
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
Ibuprofen
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 29, 2016