Paracetamol Versus Ibuprofen for PDA Closure
Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 29, 2017
August 1, 2017
2.3 years
March 10, 2015
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
closure of PDA
Echo confirmed closure
6 days
Study Arms (2)
ibuprofen group
EXPERIMENTALtreatment 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
paracetamol group
EXPERIMENTALtreatment 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29695206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pricipal investigator
Study Record Dates
First Submitted
March 10, 2015
First Posted
August 29, 2017
Study Start
June 1, 2015
Primary Completion
September 1, 2017
Study Completion
January 1, 2018
Last Updated
August 29, 2017
Record last verified: 2017-08