Paracetamol Versus Ibuprofen for PDA Closure

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Paracetamol Versus Ibuprofen for PDA Closure

Official Title

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

Brief Summary

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

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

closure of PDA


Condition

Patent Ductus Arteriosus

Intervention

ibuprofen

Study Arms / Comparison Groups

 ibuprofen group
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

June 2015

Completion Date

January 2018

Primary Completion Date

September 2017

Eligibility Criteria

        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)
      

Gender

All

Ages

28 Weeks - 35 Weeks

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT03265782

Organization ID

43214321


Responsible Party

Principal Investigator

Study Sponsor

Ain Shams University


Study Sponsor

, , 


Verification Date

August 2017