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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Low SVCF prevalence
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- — to 12 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dobutamine
Patients with low SVCF in the first 12 hours of life will be randomised to receive dobutamine or placebo.
Intervention: Dobutamine (Drug)
Placebo
Patients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Low SVCF prevalence
Time Frame: From birth to the 4th day of postnatal life
Low superior vena cava flow (SVCF) prevalence (\<40cc/kg/min ) assessed with echocardiography
Secondary Outcomes
- Mortality and neurodevelopment variables(From birth until 2 years of corrected age)
- Required dose for achieving SVCF-OP-60 (≥40 cc/kg/min maintained during 60 minutes)(From birth to the 4th day of postnatal life)
- Doppler-cranial ultrasonography (PD-CUS) variables.(From birth to the 4th day of postnatal life)
- Invasive or non-invasive arterial blood pressure(From birth to the 4th day of postnatal life)
- Respiratory rate(From birth to the 4th day of postnatal life)
- Other echocardiographic variables(From birth to the 4th day of postnatal life)
- Biochemistry markers(From birth to the 4th day of postnatal life)
- NIRS variables(From birth to 24 hours of life)
- Heart rate(From birth to the 4th day of postnatal life)
- Required dose for achieving SVCF-OP (≥40 cc/kg/min)(From birth to the 4th day of postnatal life)
- Central and peripheral temperature(From birth to the 4th day of postnatal life)
- Structural brain damage markers:(From birth to discharge (approximately around 10-15 weeks))
Investigators
Adelina Pellicer
Principal investigator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
