Objective: To compare the effectiveness and complications of ibuprofen versus indomethacin treatment of patent ductus arteriosus in preterm infants.
Inclusion criteria: Gestational age between 29 weeks and six days to 35 weeks and six days, Between 1000 and 2500 gr birth weight, Age 72 to 120 hours after birth.
Exclusion criteria:Congenital heart disease, Life-threatening infection, Liver failure, Severe intracranial hemorrhage.
Sample size:40 infants per group
Manipulation:To a group of patients prescribed ibuprofen and indomethacin groups.
Time of manipulation:24 and 48 hours after birth
Primary outcome: Closure of patent ductus arteriosus
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111024977N1
Registration date:2015-12-16, 1394/09/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-16, 1394/09/25
Registrant information
Name
Seyedeh Masoomeh Mohaqeqi Kamal
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3663 3608
Email address
ho.mohaghegh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Ibuprofen and intravenous indomethacin for the treatment of patent ductus arteriosus in preterm infants
Public title
Comparison of oral Ibuprofen and intravenous indomethacin for the treatment of patent ductus arteriosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age between 29 weeks and six days to 35 weeks and six days; Between 1000 and 2500 gr birth weight; Age 72 to 120 hours after birth.
Exclusion criteria:Congenital heart disease; Life-threatening infection; Liver failure; Severe intracranial hemorrhage.
Age
From 1 day old to 31 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom, Saheli Street, Qom University of Medical Sciences
City
Qom
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
138
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
Thrombocytopenia
Timepoint
72 hours after intervention
Method of measurement
blood test
2
Description
Pulmonary hemorrhage
Timepoint
72 hours after intervention
Method of measurement
Examination and chest radiography
3
Description
Increased creatinine
Timepoint
72 hours after intervention
Method of measurement
blood test
4
Description
Increased bilirubin
Timepoint
72 hours after intervention
Method of measurement
blood test
Secondary outcomes
1
Description
Closure of patent ductus arteriosus
Timepoint
72 hours after intervention
Method of measurement
Using echocardiography
Intervention groups
1
Description
In the intervention group
Type of treatment:Treatment with ibuprofen
Dose: 10 mg per kg and then to 5 mg kg at 24 and 48 hours after birth
Category
Treatment - Drugs
2
Description
In the comparison group
Type of treatment:Treatment with Indomethacin
Dose: 0.2 milligrams per kilogram at 24 and 48 hours after birth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ezadi Hospital
Full name of responsible person
Seyede Masoomeh Mohaqeqi Kamal
Street address
Number 28, Alley 27, Emam St.
City
Qom
2
Recruitment center
Name of recruitment center
Masoumeh Hospital
Full name of responsible person
Seyede Masoomeh Mohaqeqi Kamal
Street address
Number 28, Alley 27, Emam St.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Saheli St, University of Medical Sciences, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom university of medical sciences
Full name of responsible person
Seyedeh Masoomeh Mohaqeqi Kamal
Position
MD student
Other areas of specialty/work
Street address
Qom university of medical sciences
City
Qom
Postal code
Phone
+253 6633608
Fax
Email
hosseinmohaqeq@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom university of medical sceinces
Full name of responsible person
Mohammad HosseinArjmand
Position
Associate proffesor
Other areas of specialty/work
Street address
Qom university of medical sceinces
City
Qom
Postal code
Phone
+253 6615801
Fax
Email
arjmand.arj@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Seyed Hossein Mohaqeqi Kamal
Position
Assistant Professor
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Evin, Koodakyar Blv, Tehran, Iran
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0048
Fax
+98 21 2218 0048
Email
hosseinmohaqeq@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)