Paracetamol Versus Ibuprofen for PDA Closure

August 28, 2017 updated by: Rania Ali El-Farrash, Ain Shams University

Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gestational age ≤ 35 weeks
  2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA
  3. Urine output more than 1 ml/kg/hr
  4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

  1. Congenital heart diseases of any type including

    • Pulmonary stenosis
    • Anomalus in pulmonary venous drainage
    • Ventricular septal defect
  2. Major congenital anomalies as hydrops fetalis
  3. Low platelets count (less than 60, 000/mm3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ibuprofen group
treatment of pda with oral ibuprofen with a loading dose 10 mg/kg/ds in the first day followed by 5 mg/kg/ds in the second ant third days then a follow up echo is done
Drug: ibuprofen
drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
Other Names:
  • brufen
Experimental: paracetamol group
treatment of pda with oral paracetamol with dose of 15 mg/kg/ds every 6 hours for 3 days then a follow up echo is done
Drug: paracetamol
drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days
Other Names:
  • cetal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
closure of PDA
Time Frame: 6 days
Echo confirmed closure
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43214321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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