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

August 31, 2011
April 5, 2016
April 2011
October 2012   (final data collection date for primary outcome measure)
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 ]
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01428180 on ClinicalTrials.gov Archive Site
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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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Preterm neonates with patent ductus arteriosus treated in our hospital
  • Prematurity of Fetus
  • 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.
  • Drug: Ibuprofen
    3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
  • Indomethacin
    Infants treated with Indomethacin
    Intervention: Drug: Indomethacin
  • Ibuprofen
    Infants treated with Ibuprofen
    Intervention: Drug: Ibuprofen
  • Ligation
    Infants undergoing surgical ligation
    Intervention: Procedure: Surgical Ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2016
October 2012   (final data collection date for primary outcome measure)

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
Both
up to 34 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01428180
ULMNEONIRS03
No
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Manuel Schmid, University of Ulm
University of Ulm
Not Provided
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
University of Ulm
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP