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

Phase 3CompletedNCT02002741
Rambam Health Care Campus24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

24

Conditions

Ductus Arteriosus, Patent

Interventions

ParacetamolDRUG

Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h

PlaceboDRUG

Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Eligibility

Sex: ALLMin age: 2 DaysMax age: 2 Months
Medical Language ↔ Plain English
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

Locations (1)

Rambam Medical Center

Haifa, Israel

Outcomes

Primary Outcomes

The incidence of patent ductus arteriosus closure

By echocardiography

Time frame: 3-10 days after first dose of Ibuprofen + study drug

Secondary Outcomes

Adverse effects

Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records

Time frame: until discharge home (usually within 2-3 months since recruitment)

The need for surgical ligation for PDA

need for surgical ligation for PDA

Time frame: 3-21 days after first dose of Ibuprofen + study drug

Data from ClinicalTrials.gov

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