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Clinical Trials/NCT01251939
NCT01251939CompletedNot Applicable

Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants

Zekai Tahir Burak Women's Health Research and Education Hospital1 site in 1 country30 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Days to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nilufer Guzoglu

MD

Zekai Tahir Burak Women's Health Research and Education Hospital

Study Sites (1)

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