Paracetamol for Patent ductus arteriosus

Inclusion criteria

• {"criterion_text":"- Neonates with birth weight less than 1000g, inborn or transferred from other hospitals\n- Decision made by the treating team to provide intensive care\n- 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"}

Exclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- *Applicable to Czech Republic sites only: Proven Rhesus incompatibility with isoimmunisation*\n- Participation in another interventional study involving intravenous IMP\n- *Applicable to Czech Republic sites only: Birth Weight <500g*\n- *Applicable to Czech Repblic sites only: Birth Gestational Age <23 weeks of gestation*\n- The treating clinician does not intend to offer the infant intensive care.\n- Bidirectional shunt of PDA on fnECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).\n- Grade II – IV IVH on point of care cranial ultrasound (CRUSS) on screening (between six to twelve hours of age).\n- Pulmonary haemorrhage (PH) prior to study commencement\n- Severe persistent pulmonary hypertension of the newborn (PPHN).\n- History or examination suggestive of liver failure prior to study commencement"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.","definition_or_measurement_approach":"Assessed at discharge; PIVH defined as ≥grade II; NEC defined as ≥grade IIa (Bell's staging)."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Chronic lung disease (CLD) assessed at 36 weeks corrected gestational age (CGA). Other secondary endpoints assessed at discharge home. Developmental outcome at 2 years corrected gestational age to be assessed by Bayley’s assessment (phase 3, not part of this protocol)."}

Czechia

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

458

Number Of Sites

3

Number Of Participants

90

Ireland

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

28-10-2025

Processing Time Days

456

Number Of Sites

2

Number Of Participants

138

Primary sponsor

Full Name

University College Dublin

Organisation Type

Educational Institution

Country Of Registered Address

Ireland

Third parties

• {"country":"Ireland","full_name":"Health Research Board (Ireland)","duties_or_roles":"Source of monetary support","organisation_type":""}