Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants – The ACEDUCT Trial
- Conditions
- Patent ductus arteriosus (PDA)MedDRA version: 20.0Level: LLTClassification code: 10034129Term: Patent ductus arteriosis Class: 10010331Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-503209-13-00
- Lead Sponsor
- Royal College Of Surgeons In Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 310
1.Preterm infants born <27+0 weeks gestational age admitted to one of four study NICUs: Mount Sinai Hospital, Sunnybrook Health Sciences Centre, McMaster Children’s Hospital, or the Rotunda Hospital, 2.Permission given by the attending clinician to approach and then consent obtained from parents, 3.Diagnosis of PDA = 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt, 4.Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
1.Chromosomal anomaly, 10.Cases of severe hepatocellular insufficiency., 2.Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L, 3.Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94, 4.Platelet count <50,000 per microliter and no plan to transfuse platelets, 5.Permission denied by the attending clinician to approach parents, 6.Parental consent not available, 7.Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment)., 8.Use of any other investigational medicinal product within previous 30 days, 9.Any other medical condition/or treatment that contraindicates treatment with paracetamol or ibuprofen, such ashypersensitivity to paracetamol, propacetamol hydrochloride, or to any of the excipients listed in Section 6.1 of the SmPC for Paracetamol 10mg/ml solution for infusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).<br>Primary objective: To reduce the incidence of bronchopulmonary dysplasia or death in ELGANs receiving pharmacotherapy for PDA, by reducing treatment failure with the use of combination regime.;Secondary Objective: Secondary objective: To examine the safety and impact of the combination regime on other neonatal morbidities.;Primary end point(s): Primary outcome: Composite of pre-discharge mortality or any grade BPD, defined as need for oxygen or positive pressure respiratory support at 36 weeks postmenstrual age.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):i) PDA treatment success, defined as PDA closure or becoming insignificant [diameter <1.5 mm]. ii) Renal or hepatic dysfunction occurring within 7 days of treatment initiation, as defined under exclusion criteria. iii) Further exposure to PDA treatments (these will be as per units’ standard practice, not part of this study). iv) Procedure for PDA closure. v)Mortality;Secondary end point(s):vi) severity of BPD at 36 weeks postmenstrual age using Jensen’s criteria recently shown to be the definition which best predicted early childhood morbidities (grade 1, nasal cannula =2 L/min; grade 2, nasal cannula >2 L/min or noninvasive positive airway pressure; grade 3, invasive mechanical ventilation), vii) NEC = stage 2A. viii) Duration (days) of invasive or non-invasive respiratory support. ix) Diuretic use during NICU stay. x) Exposure to postnatal steroids. xi) Sepsis during NICU stay