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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patent Ductus Arteriosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Indo

Infants that are treated with indomethacin

INVOS Cerebral/Somatic oximeter

Intervention Type DEVICE

Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

Neo

Infants treated with neoprofen

INVOS Cerebral/Somatic oximeter

Intervention Type DEVICE

Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

Control

Infants without PDA

INVOS Cerebral/Somatic oximeter

Intervention Type DEVICE

Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

Interventions

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INVOS Cerebral/Somatic oximeter

Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No