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

Patent Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00554307
• Other study ID #: UofL IRB 328.07
• Status: Withdrawn
• Phase: N/A
• First received: November 2, 2007
• Last updated: January 22, 2015
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2015
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

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.

Locations

Country	Name	City	State
United States	Kosair Children's Hospital	Lousiville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Measure oxygenation/blood flow to brain during PDA treatment		Study period	No
Secondary	Oxygenation during/after treatment with PDA therapy		Study period	No