ClinicalTrials.gov
ClinicalTrials.gov Menu

Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01251939
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Nilufer Guzoglu, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.

Condition or disease Intervention/treatment
Ductus Arteriosus, Patent Device: Near-infrared spectroscopy (NIRS)

Detailed Description:
Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012


Group/Cohort Intervention/treatment
Treatment with ibuprofen
Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and echocardiographic evidence of hemodynamically significant PDA
Device: Near-infrared spectroscopy (NIRS)
Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.
Other Name: INVOS 4100 oximeter, Somanetics,
Controls
Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and without significant PDA
Device: Near-infrared spectroscopy (NIRS)
Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.
Other Name: INVOS 4100 oximeter, Somanetics,




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants who born in Zekai Tahir Burak Maternity and Teaching Hospital between january 2011 and january 2012 and met the entry criteria first underwent echocardiography and cranial ultrasonography.
Criteria

Inclusion Criteria:

  • Gestational age <32 weeks and <1500 g
  • Echocardiographic evidence of hemodynamically significant patent ductus arterious

Exclusion Criteria:

  • Major congenital anomalies
  • Intraventricular hemorrhage of grade 3 within the previous 24 hours
  • Serum creatinine level 1.5 mg%,serum urea nitrogen concentration >50 mg%,
  • Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
  • Hyperbilirubinemia necessitating exchange transfusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251939


Locations
Turkey
Zekai Tahir Burak Maternity and Teaching Hospital
Ankara, Turkey
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: Nilufer Guzoglu Zekai Tahir Burak Women's Health Research and Education Hospital

Responsible Party: Nilufer Guzoglu, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT01251939     History of Changes
Other Study ID Numbers: n7860088
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
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