Patent Ductus Arteriosus MedDRA version: 20.0 Level: PT Classification code 10034130 Term: Patent ductus arteriosus System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Paracetamol
Product Name: Paracetamol
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg/ml milligram(s)
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - They are inborn or transferred to a participating centre after birth and have a birth weight of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18. - The treating clinician does not intend to offer the infant intensive care. - Bidirectional shunt of PDA on ECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting). - Grade II – IV IVH on point of care CRUSS on screening (between six to twelve hours of age). - PH prior to study commencement. - Severe PPHN. - History or examination suggestive of liver failure prior to study commencement. - Written informed consent has not been obtained before the infant is 12 hours of age, or the infant’s parent(s)/guardian(s) withdraw consent prior to commencement of the trial processes or assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To investigate the efficacy of early targeted treatment of PDA, in ELBW infants, with intravenous paracetamol infusion compared with placebo, in preventing or reducing further known complications associated with PDA, as well as recording a number of known variables relating to prematurity from enrolment in the trial until discharge home from the hospital. ;Primary end point(s): •Combined outcome of periventricular/intraventricular haemorrhage (PIVH) = grade II, NEC = grade IIa (Bell's staging), and death before discharge.;Timepoint(s) of evaluation of this end point: before discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PDA closure rate • PDA exposure i.e. duration of time lived with PDA • Pulmonary haemorrhage (PH) • Spontaneous intestinal perforation (SIP) • Chronic Lung Disease of prematurity (CLD) (defined as need of oxygen and/or ventilatory support at 36 weeks of gestation) • Retinopathy of Prematurity (ROP) =grade III • Ventilation parameters during and after the study period • Use of inotropes during the study period • PDA medical treatment after the study period • PDA surgical treatment after the study period • Liver function tests • Neonatal pain score during the study period • Developmental outcome at two years corrected gestational age, as assessed by Bayley assessment will be carried out (ETAPA phase 3). ;Timepoint(s) of evaluation of this end point: Each endpoint will be measured through the course of the trial, as outlined in the endpoint list in section E.5.2 | — |
Countries
Czech Republic, Ireland
Contacts
Public ContactMonitoring
UCD
Outcome results
None listed