Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants

Autores de IIS La Fe

• Maria Del Carmen Bravo Laguna

  Autor

• Paloma Lopez Ortego

  Autor

• Fernando Cabañas Gonzalez

  Autor

• Antonio Pellicer Martínez

  Autor

Participantes ajenos a IIS La Fe

• Sánchez L
• Riera J
• Madero R

Grupos

• Medicina Reproductiva

  

  Investigador Principal

  José Morales Roselló

Abstract

Objective To gather information for a future confirmatory trial of dobutamine (DB) for circulatory impairment (ie, low superior vena cava [SVC] flow). Study design 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 mu g/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). Conclusion 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.

Keywords

• SYSTEMIC BLOOD-FLOW; BIRTH-WEIGHT INFANTS; NEAR-INFRARED SPECTROSCOPY; PRETERM INFANTS; CARDIOVASCULAR SUPPORT; PREMATURE-INFANTS; NEURODEVELOPMENT; DOPAMINE; CIRCULATION; HEMORRHAGE