title: Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants.
abstract: OBJECTIVE
  To gather information for a future confirmatory trial of dobutamine (DB) for circulatory impairment (ie, low superior vena cava [SVC] flow).
  
  
  METHODS
  A total of 127 infants born at < 31 weeks gestational age were serially scanned from birth to 96 hours after birth. The infants were randomly assigned to 2 groups and were treated with DB (stepwise dose increase, 5-10-15-20 μg/kg/min) or placebo if they had an SVC flow < 41 mL/kg/min within the first 24 hours after birth. The primary outcome measures were the achievement and maintenance of an SVC flow ≥ 41 mL/kg/min. Secondary outcome measures were the short-term evolution of clinical and biochemical variables, near-infrared spectroscopy, cranial Doppler ultrasound, and clinical outcomes.
  
  
  RESULTS
  SVC flow increased throughout the first 96 hours for the entire cohort. All of the randomized infants (n = 28) except 2 achieved and maintained an SVC flow ≥ 41 mL/kg/min after intervention; however, the infants treated with DB (n = 16) showed a higher heart rate and improved base excess compared with those treated with placebo (n = 12). Low SVC flow was associated with low gestational age (P = .02) and poor condition at birth (P = .02). Low SVC flow significantly increased the risk of severe ischemic events (OR, 13; 95% CI, 2.4-69.2; P < .01).
  
  
  CONCLUSIONS
  This exploratory trial demonstrates a tendency toward improved short-term clinical and biochemical perfusion variable outcomes in infants with low SVC flow treated with DB.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01605279) and the European Clinical Trials Database (EurodraCT 2009-010901-35).
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: María Carmen
authors.initials: MC
authors.lastname: Bravo
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Paloma
authors.initials: P
authors.lastname: López-Ortego
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Sánchez
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain; Department of Bioengineering and Nanotechnology, Polytechnic University of Madrid, Madrid, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Riera
authors.affiliation: Division of Statistics, La Paz University Hospital, Madrid, Spain.
authors.forename: Rosario
authors.initials: R
authors.lastname: Madero
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Cabañas
authors.affiliation: Department of Neonatology, La Paz University Hospital, Madrid, Spain.
authors.forename: Adelina
authors.initials: A
authors.lastname: Pellicer
mesh_terms: D058665:Adrenergic beta-1 Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D001783:Blood Flow Velocity / Q000187:drug effects / Q000502:physiology; D002316:Cardiotonic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004280:Dobutamine / Q000008:administration & dosage / Q000627:therapeutic use*; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D010865:Pilot Projects; D012039:Regional Blood Flow / Q000187:drug effects*; D013030:Spain; D019265:Spectroscopy, Near-Infrared; D016896:Treatment Outcome; D014683:Vena Cava, Superior / Q000187:drug effects* / Q000502:physiology
chemical_list: D058665:Adrenergic beta-1 Receptor Agonists; D002316:Cardiotonic Agents; D004280:Dobutamine