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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nilufer Guzoglu, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01251939
First received: November 29, 2010
Last updated: August 19, 2012
Last verified: August 2012
  Purpose

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 Intervention
Ductus Arteriosus, Patent
Device: Near-infrared spectroscopy (NIRS)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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,

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nilufer Guzoglu, MD, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01251939     History of Changes
Other Study ID Numbers: n7860088
Study First Received: November 29, 2010
Last Updated: August 19, 2012
Health Authority: Turkey: Ethics Committee

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2014