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Paracetamol Versus Ibuprofen for PDA Closure

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ClinicalTrials.gov Identifier: NCT03265782
Recruitment Status : Unknown
Verified August 2017 by Rania Ali El-Farrash, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: ibuprofen Drug: paracetamol Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018


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 Name: 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 Name: cetal




Primary Outcome Measures :
  1. closure of PDA [ Time Frame: 6 days ]
    Echo confirmed closure



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Ages Eligible for Study:   28 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rania Ali El-Farrash, pricipal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03265782     History of Changes
Other Study ID Numbers: 43214321
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Rania Ali El-Farrash, Ain Shams University:
efficacy
safety
paracetamol
ibuprofen
PDA
preterms
Additional relevant MeSH terms:
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Ibuprofen
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics