Randomized controlled trial of two different doses of intravenous paracetamol for PDA closure in preterm infants less than 30 weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PDA closure rate in low dose and high dose paracetamol group. PDA closure is defined as absence of flow through the ductus.
研究概览
简要总结
The primary purpose of the study is to compare the efficacy of higher dose (15mg/kg/dose, 4 times a day for 5 days) versus lower dose (10mg/kg/dose 4 times a day for 3 days) of intravenous paracetamol in the closure of PDA in infants less than 30 weeks gestation and having hemodynamically significant PDA.
Eligible infants will be allocated to one of the 2 groups after taking written informed consent from the parents. Daily echocardiographic examination will be performed during the intervention to look for PDA closure.
This is a non inferiority trial. Estimated closure rate in higher dose paracetamol group to be 90% with accepted non inferiority margin of 20%. For power of study to be 80% with confidence interval of 95%, the sample size required in both groups is 50 (total 100).
Recruitment for the study has been completed - December 2020. The primary outcome will be assessed using an intention to treat analysis and per protocol analysis (excluding patients that did not receive the full course of the assigned intervation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm infants with a) gestation age less than 28weeks or b) between 28-30 weeks on invasive mechanical ventilation or on CPAP with FiO2 requirements more than 35% AND having 2D echocardiographic evidence of hemodynamically significant PDA (duct size more than 1.5mm narrowest internal diameter, Left Atrium/Aorta more than 1.5, left to right flow across shunt, reversal of flow in distal aorta) diagnosed at 18-24 hours of life.
排除标准
- •1.Infants having complex cyanotic heart disease or duct dependent cardiac lesion.
- •2.Infants who were admitted to hospital after 72 hours of life.
- •4.Antenatal diagnosed serious congenital anomaly such as multicystic dysplastic kidney and polycystic disease of kidney) 5.maternal tocolytic therapy with indomethacin or another prostaglandin inhibitor within 72 hrs prior to delivery.
结局指标
主要结局
PDA closure rate in low dose and high dose paracetamol group. PDA closure is defined as absence of flow through the ductus.
时间窗: Day 6 of life
次要结局
- All cause Mortality.(During NICU stay)
- Duct reopening rate.(During NICU stay)
- Requirement of multiple courses/higher doses(During NICU stay)
- Requirement of ibuprofen/indomethacin(During NICU stay)
- Surgical ligation rate.(During NICU stay)
- Rate of adverse effects (increased S.creatinine {more than 1 mg%}, oliguria {urine output less than 0.5ml/kg/hr for 6 hours}, increased transaminases level {more than 2 times ULN}, thrombocytopenia {platelet count less than 100000/mm3}, gastrointestinal hemorrhage).(end of first week of life)
- Number of days on invasive mechanical ventilation/ NIV/ oxygen therapy(During NICU stay)
- Duration of hospital stay(NICU stay)
- Retinopathy of prematurity requiring treatment (injection avastin or laser)(During NICU stay)
- Bronchopulmonary dysplasia(During NICU stay)
- Intraventricular hemorrhage (all grades and grade 3 and grade 4)(During NICU stay)
- NEC (grade 2 and 3)(During NICU stay)
- Periventricular leukomalacia(During NICU stay)