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

Phase 2

Completed

• Conditions: Ductus Arteriosus, Patent
• Interventions: Drug: Paracetamol; Drug: Placebo

• Registration Number: NCT02002741
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-12-01
• Study First Posted: 2013-12-06
• Study Start: 2014-08-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen + Paracetamol	Paracetamol	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
Ibuprofen + Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
The incidence of patent ductus arteriosus closure	3-10 days after first dose of Ibuprofen + study drug	By echocardiography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel