Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 2, 2007
June 25, 2010
November 2007
Not Provided
  • 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 ]
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 ]
Complete list of historical versions of study NCT00554307 on ClinicalTrials.gov Archive Site
Oxygenation during/after treatment with PDA therapy [ Time Frame: Study period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Preterm infants with patent ductus arteriosus requiring medical intervention

Patent Ductus Arteriosus
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.
  • Indo
    Infants that are treated with indomethacin
    Intervention: Device: INVOS Cerebral/Somatic oximeter
  • Neo
    Infants treated with neoprofen
    Intervention: Device: INVOS Cerebral/Somatic oximeter
  • Control
    Infants without PDA
    Intervention: Device: INVOS Cerebral/Somatic oximeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2009
Not Provided

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
Both
Not Provided
No
Contact: Dan L Stewart, MD 502 852 8470 dlstew01@louisville.edu
United States
 
NCT00554307
UofL IRB 328.07
No
DStewart, ULouisville
University of Louisville
H. Lundbeck A/S
Principal Investigator: Dan L Stewart, MD University of Louisville
University of Louisville
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP