Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ductal closure
研究概览
简要总结
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
详细描述
The purpose of this randomized, placebo-controlled, double-blind, phase 2, one center clinical trial is to study the efficacy and safety of early (< 96 h) intravenous paracetamol in prophylactic closure of ductus arteriosus in extremely premature (gestational age <28+0 wk, ELGA) or low birth weight (<1000 g, ELBW) infants. The infants born extremely preterm or low birth weight are a focus of the study, since a small phase 2 study on paracetamol failed to demonstrate contraction of ductus arteriosus.
In the investigator's previous cohort of ELGA/ELBW infants, the numbers of patients who needed any therapies for patent ductus arteriosus (PDA) were 29 (23%) in the paracetamol exposed group, and 90 (54%) in the control group. As demonstrated in a phase 2 study, the early paracetamol treatment induced the closure of ductus arteriosus: the mean (SD) ductal closure age was 177 (338) h in the whole paracetamol group. However, in the subgroup of ELGA infants born before 28 gestation weeks (n=14), the mean (SD) ductal closure ages in the paracetamol and placebo groups were 491 (504) h and 858 (719) h, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Placebo, 0.45 % saline, is similar to paracetamol, both being clear liquids, so the staff will remain unaware which drug the patient receives. The study drug will be kept and prepared away from the NICU, at the separate ward 55 office, in a locked cabinet. The study drug will be prepared by the research nurse, the pharmacist of the ward, or during nighttime, by a nurse who does not participate in the study patients' treatment in any way.
入排标准
- 年龄范围
- — 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g
排除标准
- •Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
研究组 & 干预措施
Paracetamol
Paracetamol 10 mg/mL infusion solution, intravenous loading dose 20 mg/kg, followed by maintenance dose 7.5 mg/kg every 6 h up to 9 days
干预措施: Paracetamol 10mg/mL infusion solution (Drug)
Placebo
0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug
干预措施: Placebo (Other)
结局指标
主要结局
Ductal closure
时间窗: Neonatal intensive care unit (NICU) treatment period up to 13 weeks
Postnatal age of the observed closure of ductus arteriosus
次要结局
- Mortality(The first hospitalization period up to 19 weeks)
- Complications of prematurity(The first hospitalization period up to 19 weeks)
- Paracetamol serum levels(Study drug period up to 10 days)
- Paracetamol side effects(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Long term morbidity(The first hospitalization period up to 19 weeks)
- PDA, treated(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Near-infrared spectroscopy values(Study drug period up to 10 days)
- PDA(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Ventilatory assist(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
研究者
Outi Aikio
MD, PhD, Docent, Specialist in pediatrics and neonatology
University of Oulu