Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

Withdrawn

• Conditions: Patent Ductus Arteriosus
• Interventions: Device: INVOS Cerebral/Somatic oximeter

• Registration Number: NCT00554307
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.

Detailed Description

All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Less than or equal to 32 weeks gestation;
• Less than or equal to 1250 g;
• Mechanical ventilation;
• Echocardiographic findings of PDA with left to right shunting;
• Medical judgement of neonatologist for medical treatment;

Exclusion Criteria

• Urine output less than 1 ml/k/hr over previous 12 hours;
• Serum creatinine greater than 1.5 mg/dL;
• Platelet count less than 100,000 per cubic mm;
• Significant skin breakdown at sensor areas;
• Significant congenital anomalies
• Intraventricular hemorrhage greater than or equal to grade III

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	INVOS Cerebral/Somatic oximeter	Infants without PDA
Indo	INVOS Cerebral/Somatic oximeter	Infants that are treated with indomethacin
Neo	INVOS Cerebral/Somatic oximeter	Infants treated with neoprofen

Primary Outcome Measures

Name	Time	Method
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.	48-72 hours
Measure oxygenation/blood flow to brain during PDA treatment	Study period

Secondary Outcome Measures

Name	Time	Method
Oxygenation during/after treatment with PDA therapy	Study period

Trial Locations

Locations (1)

Kosair Children's Hospital; 🇺🇸 Lousiville, Kentucky, United States