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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by University of Louisville.
Recruitment status was Recruiting

Sponsor:

Collaborator:

H. Lundbeck A/S

Information provided by:

University of Louisville

ClinicalTrials.gov Identifier:

NCT00554307

First received: November 2, 2007

Last updated: June 25, 2010

Last verified: August 2009

History of Changes

Purpose

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	Intervention
Patent Ductus Arteriosus	Device: INVOS Cerebral/Somatic oximeter

Study Type:	Observational
Study Design:	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.

Resource links provided by NLM:

Drug Information available for: Indomethacin Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by University of Louisville:

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. [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
Measure oxygenation/blood flow to brain during PDA treatment [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oxygenation during/after treatment with PDA therapy [ Time Frame: Study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Preterm infants with patent ductus arteriosus requiring medical intervention

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554307

Contacts

Contact: Dan L Stewart, MD

502 852 8470

dlstew01@louisville.edu

Locations

United States, Kentucky
Kosair Children's Hospital	Recruiting
Lousiville, Kentucky, United States, 40202
Principal Investigator: Dan L Stewart, MD
Sub-Investigator: Stephan Pepple, MD
Sub-Investigator: Scott D Duncan, MD

Sponsors and Collaborators

University of Louisville

H. Lundbeck A/S

Investigators

Principal Investigator:

Dan L Stewart, MD

University of Louisville

More Information

No publications provided

Responsible Party:	DStewart, ULouisville
ClinicalTrials.gov Identifier:	NCT00554307 History of Changes
Other Study ID Numbers:	UofL IRB 328.07
Study First Received:	November 2, 2007
Last Updated:	June 25, 2010
Health Authority:	United States: Food and Drug Administration United States: Federal Government United States: Institutional Review Board

Keywords provided by University of Louisville:

patent ductus arteriosus
indomethacin
neoprofen
blood flow

Additional relevant MeSH terms:

Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents

Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013

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