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

Sponsor

University of Louisville (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00554307

Collaborator

H. Lundbeck A/S (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: INVOS Cerebral/Somatic oximeter

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Indo Infants that are treated with indomethacin	Device: 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.
Neo Infants treated with neoprofen	Device: 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.
Control Infants without PDA	Device: 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.

Arm

Intervention/Treatment

Indo

Infants that are treated with indomethacin

Device: 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.

Neo

Infants treated with neoprofen

Device: INVOS Cerebral/Somatic oximeter

Control

Infants without PDA

Device: INVOS Cerebral/Somatic oximeter

Outcome Measures

Primary Outcome Measures

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

Oxygenation during/after treatment with PDA therapy [Study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kosair Children's Hospital	Lousiville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville
H. Lundbeck A/S

Investigators

Principal Investigator: Dan L Stewart, MD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00554307

Other Study ID Numbers:

UofL IRB 328.07

First Posted:

Nov 6, 2007

Last Update Posted:

Jan 26, 2015

Last Verified:

Jan 1, 2015

Keywords provided by , ,

patent ductus arteriosus

indomethacin

neoprofen

blood flow

Additional relevant MeSH terms:

Ductus Arteriosus, Patent

Study Results

No Results Posted as of Jan 26, 2015