NCT01427686

Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

Effect of Dobutamine as Compared to Dopamine on Cerebral Oxygenation, Mean Arterial Pressure and Cerebral Hemodynamics in Term and Preterm Neonates With Arterial Hypotension

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 44 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output. The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.

Conditions

• Arterial Hypotension

Interventions

Type	Name	Description
DRUG	Dobutamine	Start Dobutamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dopamine.
DRUG	Dopamine	Start Dopamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dobutamine.

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-02-01
• Completion: 2016-12-01
• First posted: 2011-09-01
• Last updated: 2016-04-06

Locations

1 site across 1 country: Germany