Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns
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
2 other identifiers
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 9, 2015
March 1, 2015
2.1 years
May 22, 2012
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Low SVCF prevalence
Low superior vena cava flow (SVCF) prevalence (\<40cc/kg/min ) assessed with echocardiography
From birth to the 4th day of postnatal life
Secondary Outcomes (12)
Required dose for achieving SVCF-OP (≥40 cc/kg/min)
From birth to the 4th day of postnatal life
Required dose for achieving SVCF-OP-60 (≥40 cc/kg/min maintained during 60 minutes)
From birth to the 4th day of postnatal life
NIRS variables
From birth to 24 hours of 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
- +7 more secondary outcomes
Study Arms (2)
Dobutamine
EXPERIMENTALPatients with low SVCF in the first 12 hours of life will be randomised to receive dobutamine or placebo.
Placebo
PLACEBO COMPARATORPatients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo.
Interventions
Patients with low SVCF in the first 12 hours of life will be randomized to receive Dobutamine or Placebo. First dose: 5 microg/k/min; second dose: 10 microg/k/min; third dose: 15 microg/k/min; forth dose: 20 microg/k/min. Dobutamine concentration will be prepared in a 20 ml syringe and the dose will be adjusted so each 0.1 ml/kg per hour increase in flow rate would deliver the corresponding step-increase in the drug infusion dose. Dose increments will be 5, 10, 15, 20 microg/kg per minute The study drug was increased in a stepwise manner every 30 minutes until the optimal SVCF was attained and maintained for 60 minutes (SVCF-OP). Treatment duration: 24 hours of postnatal age, maintaining the infusion rate which achieves the SVCF-OP.
Patients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo (dextrose 5% in water, D5W, as Placebo)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adelina Pellicerlead
Study Sites (1)
La Paz University Hospital
Madrid, Madrid, 28046, Spain
Related Publications (2)
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. doi: 10.1542/peds.2006-3398.
PMID: 17671064BACKGROUNDBravo MC, Lopez-Ortego P, Sanchez L, Riera J, Madero R, Cabanas F, Pellicer A. Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants. J Pediatr. 2015 Sep;167(3):572-8.e1-2. doi: 10.1016/j.jpeds.2015.05.037. Epub 2015 Jun 24.
PMID: 26116470DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
María Carmen Bravo, PhDMD
Fundación Investigación Biomédica HULP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 24, 2012
Study Start
September 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 9, 2015
Record last verified: 2015-03