The aim of this study is to investigation the effect of acetaminophen prophylaxis on ductus arteriosus closure in premature infants under 31 weeks.
Design
Randomized clinical trials with control group, community based and pragmatic with parallel groups, non blinded
Settings and conduct
In this study, 64 premature infants admitted to the neonatal intensive care unit of Shahrekord Hajar hospital were enrolled in the study, using convenience sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants admitted to the neonatal intensive care unit, weight under 1500 grams and age under 31 weeks; In addition infants with congenital heart defects, congenital major abnormalities or chromosomal abnormalities, Apgar scores greater than 5 at five minutes after birth, symptomatic PDA require treatment with ibuprofen, vomiting or hematems in the first three days of birth, high levels of liver enzymes; infants with hydrops fetalis; infants whose mothers have a history of using nonsteroidal anti-inflammatory drugs during pregnancy; prevented from being enrolled in the study.
Intervention groups
Patients will be divided into two groups (intervention and control). The intervention group will receive acetaminophen prophylaxis (10 mg/ kg body weight every 6 hours for 5 days as drops). The control group will not receive any intervention.
After 10 days, both groups will undergo echocardiography.
In the case of ductus arteriosus, patients will receive the usual treatment (ibuprofen) and again after 1 month echocardiography will be done.
Main outcome variables
Ductus arteriosus condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042935N1
Registration date:2019-03-14, 1397/12/23
Registration timing:registered_while_recruiting
Last update:2019-03-14, 1397/12/23
Update count:0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
Abdolrahim Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 9507
Email address
kazemi.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of acetaminophen prophylaxis on ductus arteriosus closure in premature infants under 31 weeks
Public title
Effect of acetaminophen prophylaxis on ductus arteriosus closure in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants admitted to the neonatal intensive care unit
Weight under 1500 grams
Age under 31 weeks
Exclusion criteria:
Infants with congenital heart defects, congenital major abnormalities or chromosomal abnormalities
Infants whose mothers have a history of using nonsteroidal anti-inflammatory drugs during pregnancy
Infants with hydrops fetalis
Infants with Apgar scores greater than 5 at five minutes after birth
Infants with symptomatic PDA require treatment with ibuprofen
Infants have vomiting or hematems in the first three days of birth
Infants with high levels of liver enzymes
Age
To 210 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by convenience method and numbers from 1 to 64 will be assigned to infants based on enrollment order. Infants will be randomly allocated to two intervention and control groups using Random Number Generation (RNG) software. Information such as sample size, study population and number of study groups will be recorded in the software. The software will generate two groups of random numbers for intervention (n: 32) and control (n: 32) groups, according to which allocation will be done.
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
Ethics committee of Shahrekord University of Medical Sciences
Street address
Research Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.SKUMS.REC.1397.091
Health conditions studied
1
Description of health condition studied
Delayed closure of ductus arteriosus
ICD-10 code
P29.3
ICD-10 code description
Persistent fetal circulation
Primary outcomes
1
Description
Ductus arteriosus status
Timepoint
Ten and thirty days after intervention
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive acetaminophen prophylaxis 10 mg/ kg body weight, every 6 hours for 5 days as drops.
Category
Treatment - Drugs
2
Description
Control group: This group will not receive any medical treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar hospital
Full name of responsible person
Doctor Nabiollah Asadpour
Street address
Hajar Hospital, Parastar Street, Hafez Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 5505
Fax
+98 38 3224 3715
Email
n.asadpour@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyed Kamal Solati
Street address
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Ayatollah Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Fax
Email
kamal_solati@yahoo.com
Web page address
https://research.skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Nabiollah Asadpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
n.asadpour@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Nabiollah Asadpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
n.asadpour@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Doctor Nabiollah Asadpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of medicine, Shahrekord University of Medical Science, Rahmatiyeh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5653
Fax
Email
n.asadpour@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available