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Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants
María Carmen Bravo1, Paloma López-Ortego1, Laura Sánchez1
1Department of Neonatology, La Paz University Hospital, Madrid, Spain.
Insights
Dobutamine (DB) showed a tendency to improve short-term outcomes in preterm infants with low superior vena cava (SVC) flow. This exploratory trial suggests potential benefits for circulatory support in this vulnerable population.
Area of Science:
- Neonatal Physiology
- Cardiovascular Research
- Pharmacology in Premature Infants
Background:
- Low superior vena cava (SVC) flow is a concern in preterm infants (<31 weeks gestational age).
- Identifying interventions to improve SVC flow is crucial for neonatal care.
- This study aimed to gather data for a future confirmatory trial on dobutamine (DB) for circulatory impairment.
Purpose of the Study:
- To assess the efficacy of dobutamine (DB) in improving superior vena cava (SVC) flow in preterm infants.
- To gather preliminary data on the short-term clinical and biochemical effects of DB.
- To inform the design of a future confirmatory trial for DB in neonates with low SVC flow.
Main Methods:
- 127 infants born at <31 weeks gestational age were monitored from birth to 96 hours.
- Infants with SVC flow < 41 mL/kg/min were randomized to DB or placebo.
- Primary outcome: achieving and maintaining SVC flow ≥ 41 mL/kg/min; secondary outcomes included clinical and biochemical variables.
Main Results:
- SVC flow increased in the entire cohort over 96 hours.
- Most infants (26/28) achieved target SVC flow; DB group (n=16) had higher heart rate and improved base excess vs. placebo (n=12).
- Low SVC flow correlated with lower gestational age and poor birth condition, and significantly increased ischemic event risk (OR 13).
Conclusions:
- Dobutamine (DB) demonstrated a tendency towards improved short-term perfusion outcomes in preterm infants with low SVC flow.
- The findings support further investigation into DB for neonatal circulatory support.
- Low SVC flow is a significant risk factor for adverse outcomes in preterm neonates.
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 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).
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.
Trial Registration:
ClinicalTrials.gov (NCT01605279) and the European Clinical Trials Database (EurodraCT 2009-010901-35).
