The Preterm Infants' Paracetamol Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Ductus diameter mm/kg
研究概览
简要总结
Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.
This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.
详细描述
1 Hypotheses and aims: The aim of the present study is to evaluate the safety and efficacy of intravenous paracetamol in pain medication for small preterm infants in a randomized, controlled, double-blind trial. The primary outcome of the pain medication arm is the need for morphine medication (doses). The secondary outcomes are paracetamol serum concentrations, the side effects of paracetamol (possible hepatic dysfunction), neonatal and long-term morbidity, and mortality.
The primary outcome in the phase 2 ductus study-arm was diminishing of the ductal caliber at 5 days postnatal age. This study arm has been finalized and the results were published on 2016 (Härkin et al).
Hypotheses:
I. Hypothesis. Early, intravenous paracetamol is effective and safe therapy in the relief of pain and discomfort of a preterm infant.
II. Hypothesis. Paracetamol levels of a preterm infant remain in safety limits with study dosages.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants born < 32 weeks gestational age
排除标准
- •congenital malformation
- •lethal disease
- •chromosomal abnormality
- •persistent pulmonary hypertension of a newborn
研究组 & 干预措施
Paracetamol effect on ductus
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
干预措施: paracetamol (Drug)
Paracetamol effect on ductus
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
干预措施: 0.45 % saline solution (Drug)
Paracetamol effect on pain
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
干预措施: paracetamol (Drug)
Paracetamol effect on pain
The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN ®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg and the maintenance dose 7.5 mg kg every 6 hours for 4 days.
干预措施: 0.45 % saline solution (Drug)
结局指标
主要结局
Ductus diameter mm/kg
时间窗: at postnatal age of 5 days
Measured by cardiac ultrasound
Cumulative dosage of morphine
时间窗: at postnatal age of 5 days
The amount of morphine doses administerd during the study
次要结局
- Number of apneic periods/day(up to 5 days postnatal age)
- Duration of mechanical ventilation(participants will be followed for the duration of NICU stay, an expected average of 12 weeks)
- Postnatal age of ductus closure(participants will be followed for the duration of NICU stay, an expected average of 12 weeks)
- Number of patients who received any treatment for persistent ductus arteriosus(participants will be followed for the duration of NICU stay, an expected average of 12 weeks)
- Left atrium to aorta ratio(participants will be followed for the duration of NICU stay, an expected average of 12 weeks)
- NIAPAS screening scores(up to 5 days postnatal age)
研究者
Outi Aikio
Specialist in Pediatrics and Neonatology, M.D., Ph.D.
University of Oulu