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

Ductus Arteriosus, Patent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251939
• Other study ID #: n7860088
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: August 19, 2012
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity and Teaching Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey,