Back to resultsParacetamol Versus Ibuprofen for PDA Closure
Primary Purpose
Patent Ductus Arteriosus
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ibuprofen
paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring efficacy, safety, paracetamol, ibuprofen, PDA, preterms
Eligibility Criteria
Inclusion Criteria:
- Gestational age ≤ 35 weeks
- Aged 2-7 days with color Doppler echocardiographic evidence of PDA
- Urine output more than 1 ml/kg/hr
- 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:
Congenital heart diseases of any type including
- Pulmonary stenosis
- Anomalus in pulmonary venous drainage
- Ventricular septal defect
- Major congenital anomalies as hydrops fetalis
- Low platelets count (less than 60, 000/mm3)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ibuprofen group
paracetamol group
Arm 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
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
Outcomes
Primary Outcome Measures
closure of PDA
Echo confirmed closure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03265782
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
efficacy, safety, paracetamol, ibuprofen, PDA, preterms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen group
Arm Type
Experimental
Arm 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
Arm Title
paracetamol group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Other Intervention Name(s)
brufen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
cetal
Intervention Description
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
Primary Outcome Measure Information:
Title
closure of PDA
Description
Echo confirmed closure
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age ≤ 35 weeks
Aged 2-7 days with color Doppler echocardiographic evidence of PDA
Urine output more than 1 ml/kg/hr
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:
Congenital heart diseases of any type including
Pulmonary stenosis
Anomalus in pulmonary venous drainage
Ventricular septal defect
Major congenital anomalies as hydrops fetalis
Low platelets count (less than 60, 000/mm3)
12. IPD Sharing Statement
Citations:
PubMed Identifier
29695206
Citation
El-Farrash RA, El Shimy MS, El-Sakka AS, Ahmed MG, Abdel-Moez DG. Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Matern Fetal Neonatal Med. 2019 Nov;32(21):3647-3654. doi: 10.1080/14767058.2018.1470235. Epub 2018 May 9.
Results Reference
derived
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Paracetamol Versus Ibuprofen for PDA Closure
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