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Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA)
EU CTIS ID: 2024-516846-20-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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, T18.
- 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*
See the full eligibility criteria
- 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
- 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, T18.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.