Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min
研究概览
简要总结
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born with up to 32(+6) weeks gestation
- •Presence of hemodynamic insufficiency, defined as SVC flow <51 ml/kg/min.
- •Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.
排除标准
- •Neonates considered non-viable, with a clinical decision not to provide life support
- •Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
- •Infants already on dobutamine treatment
- •Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)
- •Infants with chromosomal anomalies
- •Lack of parental signed informed consent
研究组 & 干预措施
Dobutamine dose A
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
干预措施: Intravenous dobutamine 5 mcg/kg/min (Drug)
Dobutamine dose B
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
干预措施: Intravenous dobutamine 7.5 mcg/kg/min (Drug)
Dobutamine dose C
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
干预措施: Intravenous dobutamine 10 mcg/kg/min (Drug)
Dobutamine dose D
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
干预措施: Intravenous dobutamine 12.5 mcg/kg/min (Drug)
Dobutamine dose E
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
干预措施: Intravenous dobutamine 15 mcg/kg/min (Drug)
结局指标
主要结局
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min
时间窗: 1 and 3 hours
Short-term pharmacodynamics (PD) endpoint: Minimum dobutamine dose to reach and maintain a superior vena cava (SVC) flow above 55 ml/kg/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose. The effective start of the infusion (t0) will be calculated as the time at which the infusion pump is switched on plus the empirical value for the interval arising from the dead space. We summarize t0 as "the time at which dobutamine is expected to reach the circulation"
次要结局
- Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status(72 hours)
- Absolute and relative frequencies of adverse events and severe adverse events(Through study completion, an average of 12 months)