Comparison of the effect of adjunctive therapy with phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome
Design
Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome as adjunctive therapy
Settings and conduct
Neonatal Intensive care unit of Afzalipour Hospital of Kerman
Participants/Inclusion and exclusion criteria
Hospitalized neonates with a gestational age of 35 weeks and older with neonatal abstinence syndrome
Intervention groups
Infants hospitalized with neonatal abstinence syndrome
Main outcome variables
Duration of hospitalization
Duration of treatment
Readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053444N2
Registration date:2022-02-25, 1400/12/06
Registration timing:prospective
Last update:2022-02-25, 1400/12/06
Update count:0
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
Zahra Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8198
Email address
z.jamali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome as adjunctive therapy
Public title
Comparison of the effect of phenobarbital and levetiracetam in the treatment of neonatal abstinence syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized neonates with a gestational age of 35 weeks and older with moderate to severe neonatal abstinence syndrome
Exclusion criteria:
Infants under 35 weeks of gestation
Infants with intrauterine growth restriction
Infants with congenital major anomalies
Infants who have a cause other than neonatal abstinence syndrome for their hospitalization
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Afzalipour Educational and Medical Center - Kerman University of Medical Sciences
Street address
22 Bahman Blvd
City
kerman
Province
Kerman
Postal code
7616913355
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.KMU.AH.REC.1400.165
Health conditions studied
1
Description of health condition studied
Neonatal abstinence syndrome
ICD-10 code
P96.1
ICD-10 code description
Neonatal withdrawal symptoms from maternal use of drugs of addiction
Primary outcomes
1
Description
Infants with neonatal abstinence syndrome
Timepoint
1,3,6,10,14
Method of measurement
Finnegan Scoring Criteria
2
Description
Response rate to adjuvant therapy with levotiracetam compared with phenobarbital
Timepoint
1,3,6,10,14
Method of measurement
Finnegan Scoring Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neonates with neonatal abstinence syndrome underwent Adjunctive therapy with levetiracetam
Category
Treatment - Drugs
2
Description
Control group: Neonates with neonatal abstinence syndrome underwent Adjunctive therapy with phenobarbital
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
زهراجمالی
Street address
Emam Blvd., Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Street address
Emam Blvd., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Blvd., Afazalipour Hospital
City
کرمان
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
َAssistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Blvd., Afazlipour Hospital
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Blvd., Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.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