OBJECTIVE: Comparison of oral ibuprofen versus acetaminophen in premature infants with patent ductus arteriosus (PDA).
Type of Study: Double Blinded Clinical Trial with Randomized Controls.
Methodology & Research Design:
A. Study Sample: Premature infants with patent ductus arteriosus (PDA( borned in Kosar Hospital-Iran.
o Inclusion Criteria: Gestational age less than or equal to 34 weeks; Birth elapsed time less than or equal to 14 days; PDA diagnosis based on echocardiography findings.
o Exclusion Criteria: Any type of congenital heart disease is to keep the blood flow needed PDA; Life-threatening infections; Grade 3-4 intraventricular hemorrhage (within recent 24 hours); Urinary output less than 1mg/kg/h in last 8 hours; Serum creatinine level higher than 88 μmol/L; platelet counts less than 109×50 per liter; Hyperbilirobinemia requiring blood transfusions; Active necrotizing enterocolitis or bowel perforation; Liver dysfunction; Gastrointestinal bleeding; Retinopathy; Bronchopulmonary dysplasia; Lack of parental consent.
o Sample Size: At least 53 patients per group.
B. Investigated intervention/s: The first group of patients treated with ibuprofen at a dose of 10 mg/kg/stat and then 5 mg/kg/12h to two doses, and the second group of patients treated with acetaminophen for two days at a dose of 15 mg/kg/6h (8 doses).
C. Intervention time: The first 14 days of life.
D. The primary outcome or consequences of the study: Echocardiographic findings indicate that closure of PDA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120425357N1
Registration date:2015-12-20, 1394/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Tahereh Jangjoo Pirbazari
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 4808
Email address
t.jangjoo@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-12-07, 1394/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral ibuprofen versus acetaminophen in premature infants with patent ductus arteriosus (PDA) in kosar Hospital-Iran
Public title
Comparison of oral ibuprofen versus acetaminophen in premature infants with patent ductus arteriosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Gestational age less than or equal to 34 weeks; Birth elapsed time less than or equal to 14 days; PDA diagnosis based on echocardiography findings. Exclusion Criteria: Any type of congenital heart disease is to keep the blood flow needed PDA; Life-threatening infections; Grade 3-4 intraventricular hemorrhage (within recent 24 hours); Urinary output less than 1mg/kg/h in last 8 hours; Serum creatinine level higher than 88 μmol/L; platelet counts less than 109×50 per liter; Hyperbilirobinemia requiring blood transfusions; Active necrotizing enterocolitis or bowel perforation; Liver dysfunction; Gastrointestinal bleeding; Retinopathy; Bronchopulmonary dysplasia; Lack of parental consent.
Age
From 1 day old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences - Children's Hospital in Qods
Street address
Qods Square
City
Qazvin
Postal code
Approval date
2014-12-31, 1393/10/10
Ethics committee reference number
20/9885/د
Health conditions studied
1
Description of health condition studied
Patent ductus arteriosus
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
heart murmur
Timepoint
Before intervention - three days after the intervention.
Method of measurement
Auscultation - Echocardiography
Secondary outcomes
1
Description
Bleeding Including the gastrointestinal tract, urinary tract and respiratory tract
Timepoint
During the intervention
Method of measurement
Clinical observation and tests such as analysis of urine and faeces
Intervention groups
1
Description
The first group of patients treated with ibuprofen at a dose of 10 mg/kg/stat and then 5 mg/kg/12h to two doses.
Category
Treatment - Drugs
2
Description
The second group of patients treated with acetaminophen for two days at a dose of 15 mg/kg/6h (8 doses).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital Qazvin
Full name of responsible person
Tahereh Jangjoo Pirbazri
Street address
Vali Asr intersection - Taleghani Avenue
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abolfazl Mahyar
Street address
Qazvin -Street Shahid Bahonar
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?