The present study aims to investigate the effect of taking oral acetaminophen on closure of open arteries among immature infants hospitalized in ICU. It is a not blind clinical trial. 66 preterm infants in their pregnancy age of 34 weeks or less, who were hospitalized in Imam Reza hospital and did not respond to the prescription of oral ibuprophen twice a day, were selected and were treated by oral acetaminophen, liquid drop by Behas company, on dosage of 15 mg/kg every 6 hours during three days. Infants being treated by acetaminophen are checked for hypothermia immediately after taking the drug and every 30 minutes till an hour after the treatment. Samples were examined at the beginning and three days after the intervention to check their arteries. Inclusion: infants with contraindication using ibuprophen (oliguria: output less than 1cc/kg/hr. plackets less than 50000. Hyperbilirubinemia with the need to jaundice. Necrotizing enterocolitis perforation of the gastrointestinal tract); infants who were not treated through taking oral ibuprophen twice a day; infants with PDA determined by echocardiography. Exclusion: Congenital heart disease with the need to PDA to keep blood flow constant; life threatening infection; Intraventricular hemorrhage at 3 and 4 grades.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122714333N26
Registration date:2015-01-27, 1393/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah university of medical sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
On the efficiency of oral acetaminophen on artery closure among premature infants hospitalized in ICU
Public title
On the efficiency of oral acetaminophen on artery closure among premature infants hospitalized in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: infants with contraindication using ibuprophen (oliguria: output less than 1cc/kg/hr. plackets less than 50000. Hyperbilirubinemia with the need to jaundice. Necrotizing enterocolitis perforation of the gastrointestinal tract); infants who were not treated through taking oral ibuprophen twice a day; infants with PDA determined by echocardiography. Exclusion: Congenital heart disease with the need to PDA to keep blood flow constant; life threatening infection; Intraventricular hemorrhage at 3 and 4 grades.
Age
From 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
420/7/پ/35219
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
Patent or closure of Ductus Arteriosus
Timepoint
By a doctor
Method of measurement
At the beginning of the intervention and three after that
Secondary outcomes
empty
Intervention groups
1
Description
Experiment group included infants who were not treated through taking oral ibuprophen twice a day and were checked to be treated through taking oral acetaminophen with dose of 15 mg/kg every 6 hours for three days. Infants being treated by acetaminophen are checked for hypothermia immediately after taking the drug and every 30 minutes till an hour after the treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal intensive care unit, Emamreza hospital
Full name of responsible person
Dr. Raheleh Nemati
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homa Babaei
Position
Neonatologist
Other areas of specialty/work
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
HOMA_BABAEI@KUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)