Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Low systemic flow as measured by Doppler-echocardiography has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation and in newborn prognosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adelina Pellicer
• Treatments: Dobutamine

Criteria

Inclusion criteria

• Newborn infants born at ≤ 28 weeks of gestational age.

• Newborn infants born at > 28 weeks of gestational age and ≤ 30 weeks of gestational age with moderate-severe respiratory distress syndrome, defined as the necessity of respiratory support with a mean pressure ≥ 4 cm H2O or FiO2 ≥ 0.3

• Admission at the NICU in the first 6 hours of life

• Inotrope treatment absent

• Inform consent signed

Exclusion criteria

• Early systemic hypotension, defined as a mean arterial pressure (MAP) lower than the gestational age, during at least 60 minutes and maintained after volume infusion

• Major congenital malformation

• Informed consent declined