Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns
Information source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemodynamic Instability
Intervention: Dobutamine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Adelina Pellicer Official(s) and/or principal investigator(s): María Carmen Bravo, PhDMD, Principal Investigator, Affiliation: Fundación Investigación Biomédica HULP
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.
Clinical Details
Official title: Randomised Double Blind Clinical Trial of Dobutamine Versus Placebo for Low Superior Vena Cava Flow Treatment in Low Birth Weight Infants: Systematic Assessment of Cerebral and Systemic Hemodynamics Effects
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Low SVCF prevalence
Secondary outcome: Required dose for achieving SVCF-OP (≥40 cc/kg/min)Required dose for achieving SVCF-OP-60 (≥40 cc/kg/min maintained during 60 minutes) NIRS variables Doppler-cranial ultrasonography (PD-CUS) variables. Invasive or non-invasive arterial blood pressure Central and peripheral temperature Heart rate Respiratory rate Other echocardiographic variables Biochemistry markers Structural brain damage markers: Mortality and neurodevelopment variables
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: 12 Hours.
Gender(s): Both.
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
Locations and Contacts
La Paz University Hospital, Madrid 28046, Spain
Additional Information
Related publications: Osborn DA, Evans N, Kluckow M, Bowen JR, Rieger I. Low superior vena cava flow and effect of inotropes on neurodevelopment to 3 years in preterm infants. Pediatrics. 2007 Aug;120(2):372-80.
Starting date: September 2010
Last updated: March 6, 2015
|