Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
Overview
- Phase
- Phase 2
- Intervention
- Paracetamol
- Conditions
- Ductus Arteriosus, Patent
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The incidence of patent ductus arteriosus closure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ibuprofen + 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
Intervention: Paracetamol
Ibuprofen + 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.
Intervention: Placebo
Outcomes
Primary Outcomes
The incidence of patent ductus arteriosus closure
Time Frame: 3-10 days after first dose of Ibuprofen + study drug
By echocardiography
Secondary Outcomes
- Adverse effects(until discharge home (usually within 2-3 months since recruitment))
- The need for surgical ligation for PDA(3-21 days after first dose of Ibuprofen + study drug)