Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Lousiville, Kentucky 40202


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.


Study summary:

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.


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


Study is Available At:


Original ID:

UofL IRB 328.07


NCT ID:

NCT00554307


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Louisville


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:

Not able to enroll patients


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:November 2007
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 22, 2015
First Received Date:November 2, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Oxygenation during/after treatment with PDA therapy
Time Frame:Study period
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Measure oxygenation/blood flow to brain during PDA treatment
Time Frame:Study period
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:INVOS Cerebral/Somatic oximeter
Description: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 Name:Indo

Study Arms

Study Arm Type:Other
Arm Name:Control
Description:Infants without PDA
Study Arm Type:Other
Arm Name:Neo
Description:Infants treated with neoprofen
Study Arm Type:Other
Arm Name:Indo
Description:Infants that are treated with indomethacin

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Louisville
Agency Class:Industry
Agency Type:Collaborator
Agency Name:H. Lundbeck A/S

Samples and Retentions

Study Population: Preterm infants with patent ductus arteriosus requiring medical intervention
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.