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

Ductus Arteriosus, Patent research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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‚Č• 200 U/L - Significant congenital heart disease

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Ductus Arteriosus, Patent

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ParacetamolIbuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h

Drug:PlaceboIbuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ibuprofen + ParacetamolIbuprofen 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 + PlaceboIbuprofen 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.

Study Status

Recruiting

Start Date: August 1, 2014

Completed Date: December 31, 2017

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: The incidence of patent ductus arteriosus closure

Secondary Outcome: Adverse effects

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Rambam Health Care Campus

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02002741

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