NCT00554307

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.

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-11-06
• Last updated: 2015-01-26

Locations

1 site across 1 country: United States