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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01251939
Enrollment
30
Registered
2010-12-02
Start date
2011-10-31
Completion date
2012-08-31
Last updated
2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductus Arteriosus, Patent

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.

Interventions

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.

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Days to No maximum
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026