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

NCT01251939 | Completed DMC

• 1 other identifier: n7860088
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus, Patent

Study Arms (2)

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)

Controls

Gestational age \<32 weeks and \<1500 g, postnatal age older than 48 hours and without significant PDA

Device: Near-infrared spectroscopy (NIRS)

Interventions

Near-infrared spectroscopy (NIRS) DEVICE

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.

Also known as: INVOS 4100 oximeter, Somanetics,

Controls; Treatment with ibuprofen

Eligibility Criteria

• Age: 2 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity and Teaching Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Nilufer Guzoglu

  Zekai Tahir Burak Women's Health Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 2, 2010
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

TU (1)