A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score

A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score - PDA RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004526-33-IE

Enrollment

Registered

2015-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2020-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus MedDRA version: 18.1 Level: PT Classification code 10034130 Term: Patent ductus arteriosus System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Pedea 5 mg/ml solution for injection Product Name: Pedea 5 mg/ml solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: IBUPROFEN CAS Number: 57469-77-9 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All infants less than 29 weeks admitted to the NICU with a PDA identified on echocardiography between 36 and 48 hours of life will be eligible for inclusion. A comprehensive assessment of PDA significance will be performed using echocardiography to derive a PDA risk score based on this following formula: Infants with a risk score = 5.0 are deemed to be at high risk of developing CLD/Death and will be randomised to either arm (Gestation in weeks × -1.304) + (PDA diameter in mm × 0.781) + (Left ventricular output in ml/kg/min × 0.008) + (maximum PDA velocity in m/s × -1.065) + (LV a` wave in cm/s × -0.470) + 41, where 41 is the constant of the formula. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The following infants will be excluded: • lack of consent or study investigators • lethal congenital abnormality or obvious syndrome • pulmonary hypoplasia • active bleeding • known or suspected NEC • platelet count 100 µmol/L; neutropenia • oliguria < 1ml/kg/hour • congenital heart disease other than a PDA or a patent foramen ovale • grade 3 or higher IVH

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to identify infants at high risk of developing CLD/Death by utilising the PDAsc, and randomise those infants to early treatment with Ibuprofen versus placebo. We hypothesise that: • in preterm infants less than 29 weeks gestation; • at high risk of developing CLD/Death (Primary outcome) based on a PDAsc = 5.0; • obtained using echocardiography carried out between 36 and 48 hours of life; ,early treatment with non-steroidal anti-inflammatory drugs (Ibuprofen) compared with placebo will result in a reduction of CLD/Death by 36 weeks post menstrual age (PMA). Infants with a PDAsc < 5 will not be enrolled in the study but will be followed up to discharge to confirm their low risk status. ;Secondary Objective: We will collect information on important secondary outcomes including culture proven sepsis, inotrope and diuretic use, postnatal steroids administration, PDA treatment beyond day 14 of age (including PDA ligation), necrotizing enterocolitis (NEC) with radiological evidence of pneumatosis intestinalis; intraventricular haemorrhage , days on invasive ventilation/continuous positive airway pressure (CPAP)/ supplemental oxygen, hospital days, treated retinopathy of prematurity and periventricular leukomalacia. In this pilot study we also aim to ascertain issues with recruiting infants and obtaining consent, compliance with the protocol, the rate (if any) of loss to follow up, and the general acceptability, feasibility and compliance of administering the intervention. ;Primary end point(s): The primary outcome of the study is chronic lung disease defined as the need for oxygen at 36 weeks corrected age or and/or death before discharge. ;Timepoint(s) of evaluation of this end point: This will be assessed prior to hospital discharge at 36 weeks corrected age.	—

Measure

Time frame

Main Objective: We aim to identify infants at high risk of developing CLD/Death by utilising the PDAsc, and randomise those infants to early treatment with Ibuprofen versus placebo. We hypothesise that: • in preterm infants less than 29 weeks gestation; • at high risk of developing CLD/Death (Primary outcome) based on a PDAsc = 5.0; • obtained using echocardiography carried out between 36 and 48 hours of life; ,early treatment with non-steroidal anti-inflammatory drugs (Ibuprofen) compared with placebo will result in a reduction of CLD/Death by 36 weeks post menstrual age (PMA). Infants with a PDAsc < 5 will not be enrolled in the study but will be followed up to discharge to confirm their low risk status. ;Secondary Objective: We will collect information on important secondary outcomes including culture proven sepsis, inotrope and diuretic use, postnatal steroids administration, PDA treatment beyond day 14 of age (including PDA ligation), necrotizing enterocolitis (NEC) with radiological evidence of pneumatosis intestinalis; intraventricular haemorrhage , days on invasive ventilation/continuous positive airway pressure (CPAP)/ supplemental oxygen, hospital days, treated retinopathy of prematurity and periventricular leukomalacia. In this pilot study we also aim to ascertain issues with recruiting infants and obtaining consent, compliance with the protocol, the rate (if any) of loss to follow up, and the general acceptability, feasibility and compliance of administering the intervention. ;Primary end point(s): The primary outcome of the study is chronic lung disease defined as the need for oxygen at 36 weeks corrected age or and/or death before discharge. ;Timepoint(s) of evaluation of this end point: This will be assessed prior to hospital discharge at 36 weeks corrected age.

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Secondary

Measure	Time frame
Secondary end point(s): The following secondary clinical outcomes will also be obtained: culture proven sepsis, inotrope and frusemide use, postnatal steroids administration, PDA treatment beyond day 14 of age (including PDA ligation), necrotizing enterocolitis (NEC) with radiological evidence of pneumatosis intestinalis; intraventricular haemorrhage assessed on day 7 of age and classified according to Papile Classification, days on invasive ventilation/continuous positive airway pressure (CPAP)/ supplemental oxygen, hospital days, treated retinopathy of prematurity and periventricular leukomalacia. ;Timepoint(s) of evaluation of this end point: This will be assessed prior to hospital discharge at 36 weeks corrected age.	—

Measure

Time frame

Secondary end point(s): The following secondary clinical outcomes will also be obtained: culture proven sepsis, inotrope and frusemide use, postnatal steroids administration, PDA treatment beyond day 14 of age (including PDA ligation), necrotizing enterocolitis (NEC) with radiological evidence of pneumatosis intestinalis; intraventricular haemorrhage assessed on day 7 of age and classified according to Papile Classification, days on invasive ventilation/continuous positive airway pressure (CPAP)/ supplemental oxygen, hospital days, treated retinopathy of prematurity and periventricular leukomalacia. ;Timepoint(s) of evaluation of this end point: This will be assessed prior to hospital discharge at 36 weeks corrected age.

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Countries

Ireland

Contacts

Public ContactAfif EL-Khuffash

Royal College of Surgeons in Ireland

afifelkhuffash@rcsi.ie353876683387

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026