Evaluation of seizures in infants with moderate to severe asphyxia treated with intravenous acetaminophen
Design
The intervention group will include infants who will be given intravenous acetaminophen at a dose of 10 mg / kg for 3 days.
control group consisting of moderate and severe asphyxia patients who were previously admitted to the ward.
Settings and conduct
This study was performed on 60 infants with moderate to severe asphyxia admitted to the neonatal intensive care unit of Imam Reza Hospital in Mashhad. Neonates were divided into two groups. The intervention group is given intravenous acetaminophen in addition to routine treatment for asphyxia. The same group of the mentioned treatments are performed routinely. Infants are monitored for seizures during hospitalization. Babies who have evidence of seizures will have an EEG (brain scan) and the brain scan will be checked by the Neuroscience Service and will be included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Term neonates with a gestational age greater than 37 weeks with a weight over 2 kg at birth and without asymptomatic structural abnormalities, umbilical cord pH below 7 and base deficit (open deficiency) more than 12 mmol / lit and Apgar score of 4 or Less in the first minute and 6 or less in the fifth minute
Exclusion criteria: preterm infants, infants with structural abnormalities, infants under 2 kg, genetic disorders, neuromuscular disorders
Intervention groups
The intervention group will include infants who will be given intravenous acetaminophen at a dose of 10 mg / kg for 3 days.
The control group patients who were previously admitted to the ward and received routine treatments in the ward.
Main outcome variables
The main outcome of the study in the intervention group was the incidence of seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081021001378N14
Registration date:2022-06-06, 1401/03/16
Registration timing:retrospective
Last update:2022-06-06, 1401/03/16
Update count:0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Ahmadshah Farhat
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
farhata@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of seizures in infants with moderate and severe asphyxia treated with intravenous acetaminophen
Public title
Evaluation of seizures in infants with moderate and severe asphyxia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
term newborn with 37 week gestational age
more than 2 kg birth weight
pH less than 7
base deficit more than 12 mmol/lit
Exclusion criteria:
preterm infants
Anomalies
less than 2 kg birth weight
Genetic disorders
Neuromacular disorders
Age
From 1 day old to 30 days old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreshi Bul, Daneshgah Ave, Mashhad, Iran
City
Mashahd
Province
Razavi Khorasan
Postal code
3791316
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.443
Health conditions studied
1
Description of health condition studied
moderate and severe asphyxia
ICD-10 code
P21
ICD-10 code description
Birth asphyxia
Primary outcomes
1
Description
The incidence of seizures
Timepoint
duration of hospitalization
Method of measurement
Based on clinical signs
2
Description
Time of start feeding
Timepoint
From the beginning of hospitalization to the end of hospitalization
Method of measurement
Based on abdominal examination, the presence of intestinal sounds and the absence of vomiting
3
Description
feeding tolerance
Timepoint
From the beginning of feeding to the end of hospitalization
Method of measurement
Abdominal examination, clinical observation of the infant and evaluation for vomiting or malnutrition
Secondary outcomes
1
Description
Evaluation of heart disorder at the end of acetaminophen treatment
Timepoint
duration of hospitalization
Method of measurement
Based on clinical signs and then if there are echocardiographic symptoms
Intervention groups
1
Description
Intervention group: They will include infants who will be given an intravenous acetaminophen at a dose of 10 mg / kg for 3 days. Routine daily treatments are also performed.
Category
Treatment - Drugs
2
Description
Control group: Patients with supportive and routine treatment in asphyxia: cardio respiratory monitoring, respiratory support if necessary, Restriction of neonatal fluid intake and injectable erythropoietin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
neonatal intensive care unite of Imam Reza Hospital
Full name of responsible person
Mohadese Khakpour
Street address
Neonatal intensive Care Unite, Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
khakpourmh981@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayoiur Mobarhan
Street address
Ghoreshi Bul, Daneshgah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
37913316
Phone
+98 51 3852 1121
Email
khakpourmh981@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mhadese Khakpour
Position
neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
38521121
Email
khakpormh981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadese Khakpour
Position
noenatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
385521121
Email
khakpourmh981@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
محدثه خاکپور
Position
neonatologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
38521121
Email
khakpourmh981@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
All data can be shared after patients are made unidentified
When the data will become available and for how long
data can be accessible 6 months after results are published
To whom data/document is available
Data can be accessible through an email to the corresponding author
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutions
From where data/document is obtainable
After sending a request email to the corresponding author data will be sent in 2 month
What processes are involved for a request to access data/document