Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

Adelina Pellicer

Status and phase

Completed

Phase 2

Conditions

Hemodynamic Instability

Treatments

Drug: Dobutamine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01605279

2009-010901-35 (EudraCT Number)

NeoDobuta

Details and patient eligibility

About

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.

Full description

While rates of survival for very preterm infants are increasing, a significant number of these patients suffer from neurodevelopmental disabilities. The pathophysiology of brain injury in the preterm infant is unclear, although haemodynamic disturbances during the period of transitional circulation after birth leading to ischemia-reperfusion events seem to play an important role. Up to one third of infants born under 30 weeks of gestation develop low systemic flow as measured by Doppler-echocardiography (low superior vena cava flow, SVCF); this finding 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 dobutamina, DB, (inotrope-sympathicomimetic drug) has any effect on the cerebral circulation; specific interest of our research would be to target DB dose for individual patient´s response. Secondly, by means of two non-invasive technologies (cerebral and cardiac ultrasonography-Doppler and near infrared spectroscopy, NIRS), the investigators search to characterise eventual differences in brain perfusion patterns during the adaptation to the transitional circulation that might be associated with the development of brain injury in the most vulnerable population.

Enrollment

127 patients

Sex

All

Ages

Under 12 hours old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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