Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

Study Overview
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Brief Summary
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The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Detailed Description
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Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Official Title
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Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

Conditions
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Ductus Arteriosus, Patent

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born at 24-37 gestational age diagnosis of Hemodynamically significant patent ductus arteriosus Medical staff decided to treat with Ibuprofen Parents have signed informed consent Exclusion Criteria: Contraindication for ibuprofen Alanine transaminase /Aspartate transaminase≥ 200 U/L Significant congenital heart disease

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen + Paracetamol<br>Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses | Drug: Paracetamol<br>* Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h<br>* Other names: Acamol;|
| Placebo Comparator: Ibuprofen + Placebo<br>Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h. | Drug: Placebo<br>* Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of patent ductus arteriosus closure | By echocardiography | 3-10 days after first dose of Ibuprofen + study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records | until discharge home (usually within 2-3 months since recruitment) | 
| The need for surgical ligation for PDA | need for surgical ligation for PDA | 3-21 days after first dose of Ibuprofen + study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDA, patent ductus arteriosus, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen, Placebo