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

Completed

• Conditions: Ductus Arteriosus, Patent
• Interventions: Device: Near-infrared spectroscopy (NIRS)

• Registration Number: NCT01251939
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Study Start: 2011-10
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-19
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with ibuprofen	Near-infrared spectroscopy (NIRS)	Gestational age \<32 weeks and \<1500 g, postnatal age older than 48 hours and echocardiographic evidence of hemodynamically significant PDA
Controls	Near-infrared spectroscopy (NIRS)	Gestational age \<32 weeks and \<1500 g, postnatal age older than 48 hours and without significant PDA

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity and Teaching Hospital; 🇹🇷 Ankara, Turkey