Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life
研究概览
简要总结
The purpose of this study is to investigate the early use of hydrocortisone in hypotensive very low birth weight infants.
Based on the observations that:
- hypotension is a common problem in very low birthweight infants and is associated with brain injury and poor neurological outcomes;
- some infants are refractory to standard treatment (volume expansion and vasopressors), which is not exempt of adverse effects;
- relative adrenal insufficiency has been described in this population; we hypothesize that hydrocortisone is effective in the treatment of hypotension in this population and reduce the need for vasopressors.
详细描述
Eligible infants will be randomly assigned to receive hydrocortisone or placebo, using sequentially numbered, preassigned treatment designations in sealed, opaque envelopes. The study drug will be randomly assigned to each patient number, in advance, using a computer-based random number generator.
Hydrocortisone and placebo doses will be prepared and provided by the hospital pharmacy following the assigned study number. Active and placebo drug solutions will be completely indistinguishable.
Infants of multiple gestations will be randomized as separate subjects. Crossover between study groups is not allowed. Physicians involved in the care of the infants will be blinded to treatment group allocation.
If the infant remains hypotensive after a Normal Saline (NS) bolus 10 ml/kg, blood for serum cortisol level determination will be drawn and hydrocortisone or an equivalent volume of NS placebo will be administered intravenously as follows: first dose immediately after randomization 2 mg/kg; 6 hours after 1 mg/kg q6h for 3 doses; followed by 0.5 mg/kg q6hs for 4 doses. If an infant responds to the initial dose of NS but becomes hypotensive within 1 hour after will also be randomized, otherwise another NS bolus could be administered.
Initiation and escalation of inotropes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 48 Hours 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤ 30 weeks, Birth weight ≤ 1250 grams and ≤ 48 hours age;
- •Umbilical or peripheral arterial catheter in place;
- •Invasive mean blood pressure < gestational age in completed weeks after 1 Normal Saline bolus 10 ml/kg;
- •Parental/legal guardian consent.
排除标准
- •Clear evidence of hypovolemia (blood loss);
- •Chromosomal abnormalities;
- •Hydrops fetalis;
- •Major congenital anomalies;
- •Cardiac lesions other than patent ductus arteriosus.
结局指标
主要结局
Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life
时间窗: 7 days
次要结局
- Total cumulative dose of epinephrine and total dose of fluids at 48 hours of study drug administration and by day 7 of life(7 days)