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

University of Louisville (UOFL)

Status: Withdrawn

Conditions: Patent Ductus Arteriosus

Treatments: Device: INVOS Cerebral/Somatic oximeter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00554307

UofL IRB 328.07

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Indo

Description:

Infants that are treated with indomethacin

Treatment:

Device: INVOS Cerebral/Somatic oximeter

Neo

Description:

Infants treated with neoprofen

Treatment:

Device: INVOS Cerebral/Somatic oximeter

Control

Description:

Infants without PDA

Treatment:

Device: INVOS Cerebral/Somatic oximeter