2024-516846-20-00招募中3 期
Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 5
- 主要终点
- The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.
研究概览
简要总结
Our primary objective is to compare the efficacy of early targeted treatment of PDA, in ELBW infants, with intravenous Paracetamol administration compared to placebo, in reducing the combined outcomes of PIVH, NEC and death before discharge.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Neonates with birth weight less than 1000g, inborn or transferred from other hospitals
- •Decision made by the treating team to provide intensive care
- •Large PDA, defined as PDA with diameter greater than 1.5mm with non-restrictive flow (defined as diastolic flow less than 50% of systolic flow), determined by targeted functional neonatal echocardiography (fnECHO) between 6 and 12 hours of age
排除标准
- •Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO/muscular VSD <5mm), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T
- •Written informed consent has not been obtained before the infant is 12 hours of age, or subjects’ parent(s)/guardian(s) withdraws consent prior to commencement of trial assessments or processes.
- •Applicable to Czech Republic sites only: Proven Rhesus incompatibility with isoimmunisation*
- •Participation in another interventional study involving intravenous IMP
- •Applicable to Czech Republic sites only: Birth Weight <500g*
- •Applicable to Czech Repblic sites only: Birth Gestational Age <23 weeks of gestation*
- •The treating clinician does not intend to offer the infant intensive care.
- •Bidirectional shunt of PDA on fnECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).
- •Grade II – IV IVH on point of care cranial ultrasound (CRUSS) on screening (between six to twelve hours of age).
- •Pulmonary haemorrhage (PH) prior to study commencement
- •Severe persistent pulmonary hypertension of the newborn (PPHN).
- •History or examination suggestive of liver failure prior to study commencement
结局指标
主要结局
The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.
The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.
次要结局
- The secondary endpoint of CLD will be assessed at 36 weeks CGA. All other secondary endpoints will be assessed at discharge home, apart from developmental outcome at 2 years of corrected gestational age which will be assessed by Bayley’s assessment as phase 3 of ETAPA trial (and is not part of this protocol)
研究者
Jan Miletin
Scientific
University College Dublin
研究点 (5)
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