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The comparison between intravenous acetaminophen versus oral ibuprofen in preterm newborns with patent ductus arteriosus

Protocol summary

Study aim
Comparison of the effect of intravenous acetaminophen and oral ibuprofen on the closure of Patent Ductus Arteriosus in preterm infants
Design
Qualified subjects were nonrandomly divided into two groups A (injectable acetaminophen) and B (oral ibuprofen) for the presence or absence of contraindication for ibuprofen.The sample size in each group was 25 neonates. The study was performed as a non-randomized controlled clinical trial.
Settings and conduct
This study was performed prospectively.Inclusion criteria included preterm neonates admitted to the NICU of Imam Khomeini Hospital Complex with gestational ages and weights less than 37 weeks old and 2500 grams, respectively, who had hemodynamically significant PDA. Participants included 50 premature infants divided into two groups. Each participant was given a 3-days course of medicine (second course if necessary) and at the end of each course echocardiography was performed to determine response to treatment. The rate of ductal closure, need for second course of medical treatment, need for surgical treatment and side effects were recorded. Blinding method was that the participants, infants and the parents, had no information about type of medication.The statistician had also no information about type of medication.
Participants/Inclusion and exclusion criteria
All premature newborns with hemodinamically significant PDA in NICU department of Vali-Asr Hospital, Imam Khomeini Hospital Complex
Intervention groups
Group A: Intravenous acetaminophen Group B: Oral ibuprofen
Main outcome variables
closure of PDA, The need for drug re-treatment, The need for surgical treatment, Increased serum creatinine, Gastrointestinal bleeding, Necrotizing enterocolitis, Hyperbilirubinemia, Intraventricular Hemorrhage, Pulmonary Hemorrhage, Elevation of serum Aminotransferases

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190206042639N1
Registration date: 2019-09-24, 1398/07/02
Registration timing: retrospective

Last update: 2019-09-24, 1398/07/02
Update count: 0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Zeinab Harif nashtifani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8852 4107
Email address
hrf.z24@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2018-01-10, 1396/10/20
Trial completion date
2018-01-20, 1396/10/30
Scientific title
The comparison between intravenous acetaminophen versus oral ibuprofen in preterm newborns with patent ductus arteriosus
Public title
The comparison between intravenous acetaminophen versus oral ibuprofen in preterm newborns with patent ductus arteriosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with hemodynamicaiy significant Patent Ductus Arteriosus Premature infant with a gestational age of less than 37 weeks and a birth weight of less than or equal to 2500 grams
Exclusion criteria:
Ductal dependent congenital Heart diseases Life threatening infections Syndromic manifestations Persistent Pulmonary Hypertention
Age
From 1 day old to 15 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Actual sample size reached: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (premature infants) have no information about prescribing drugs. The data analyzer has no information about type of Prescribing drugs. Safety Committee and Data Supervision has no information about type of Prescribing drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Oral ibuprofen is a commonly used drug for treating PDA in premature infants in Iran.Contraindications for use in premature infants admitted to the NICU are abundant.The particular feature of our study was that we used intravenous acetaminophen (apotel) for patients who were contraindicated in taking ibuprofen and having a hemodinamicaly significant PDA. Therefore, patients who were normally deprived of treatment were treated with intravenous acetaminophen.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blv, Qods Streat, Tehran Univercity of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.290

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
closure of PDA in preterm infants
Timepoint
Echocardiography at 3 to 15 days of birth (before starting treatment), 4 days after starting treatment
Method of measurement
Echocardiographicaly

Secondary outcomes

1

Description
requires a second course of medical treatment
Timepoint
The day after the first course of medical treatment
Method of measurement
Ecocardiographicaly

2

Description
Need for surgical treatment
Timepoint
The day after the second course of medical treatment
Method of measurement
Ecocardiographicaly

3

Description
Increased serum creatinine
Timepoint
Any time after initiation of medical treatment
Method of measurement
Physical examination & laboratory tests

4

Description
Incidence of pulmonary hemorrhage
Timepoint
Any time after initiation of medical treatment
Method of measurement
Physical examination & CXR

5

Description
Incidence of intraventricular hemorrhage
Timepoint
Any time after initiation of medical treatment
Method of measurement
Physical examination & brain sonography

6

Description
Incidence of gastrointestinal bleeding
Timepoint
Any time after initiation of medical treatment
Method of measurement
Physical examination & laboratory tests

7

Description
Incidence of necrotizing enterocolitis
Timepoint
Any time after initiation of medical treatment
Method of measurement
Clinical and Paraclinical Examination

8

Description
Impaired liver function tests
Timepoint
Any time after initiation of medical treatment
Method of measurement
Clinical examination and laboratory tests

9

Description
Hyperbilirubinemia
Timepoint
Any time after initiation of medical treatment
Method of measurement
Clinical examination and laboratory tests

Intervention groups

1

Description
Intervention group: Oral ibuprofen with a dose of 10 mg per kg on the first day and then 5 mg per kilogram in the next two doses at intervals of 24 and 48 hours
Category
Treatment - Drugs

2

Description
Intervention group: Intravenous Acetaminophen With a dose of 10 mg per kg body weight every 6 hours up to a maximum of 60 mg per kg per day for 3 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, Valiasr Hospital, NICU Department
Full name of responsible person
Zeinab Harif Nashtifani
Street address
NICU Department, Valiasr Hospital,Imam Khomeini Hospital Complex, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2361
Email
HRF.Z24@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Massoud Younesian
Street address
Deputy Director of Research and Technology, Central Organization of Tehran University of Medical Sciences, Corner of Qods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
tums.edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Harif Nashtifani
Position
Pediatric Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 26, Vatani Alley, Kavosifar, Beheshti Street
City
Tehran
Province
Tehran
Postal code
1577814935
Phone
+98 21 8852 4107
Email
HRF.Z24@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behzad Mohammadpour Ahrendani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Department,Valiasr Hospital,Imam Khomeini Hospital complex, End of keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2361
Email
behzadpediatr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Harif Nashtifani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 26, Vatani Alley, Kavoosifar Ave, Beheshti Street
City
Tehran
Province
Tehran
Postal code
1577814935
Phone
+98 21 8852 4107
Email
hrf.z24@gmail.com

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data include general data, study method, data analysis method, study results and general conclusions will be Published in validated journals and will be available to the researchers.
When the data will become available and for how long
In the next solar year
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
For clinical use, sharing among other researchers and benchmarking for similar cases
From where data/document is obtainable
Dr. Behzad Mohammadpour Ahrangani, End of keshavarz Blvd, Imam Khomeini Hospital, Valiasr Hospital, Children's Department, 00982161192361, postal code 1419733141
What processes are involved for a request to access data/document
Applicants can access the study information by telephone or correspondence to the address of Dr. Behzad Mohammadpour Ahrandani.
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