Study the effect of fluoxetine on the treatment of Breath Holding Spells
Design
Clinical trials with community-based and pragmatic control group, parallel groups, randomized with Sealed envelope, which was not blinded and single-centered, included 30 BHS patients
Settings and conduct
The study was single central and was performed in Ghaem hospital of Mashhad and Blindness was not done.
Participants/Inclusion and exclusion criteria
Attacks of breath Holding Spells include cyanotype or pallid at least every 2 weeks, or more
Intervention groups
In the Intervention group BHS Children are given 1 or 2 CC fluoxetine syrup with iron drop for 3 month each morning after breakfast . The fluoxetine syrup used in this study was purchased from Abidi Company, which contains 10 mg of active substance per 10 cc. Usual consumption is 10 doses per day. In the control group, only a drop of iron is given to BHS children for 3 months each morning after breakfast
Main outcome variables
The number of Breath Holding Spells in a month
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031668N3
Registration date:2018-09-29, 1397/07/07
Registration timing:registered_while_recruiting
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
farah ashrafzadeh
Name of organization / entity
Mashhad University of Medical Seinces
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 4834
Email address
ashrafzadehf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Fluoxetine on Breath Holding Spells in Children who refer to Ghaem hospital of Mashhad
Public title
Study the effect of Fluoxetine on Breath Holding Spells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The frequency of Breath Holding Spells includes cyanootic or pallid at least every 2 weeks, once or more
Normal EKG
Parental consent
Exclusion criteria:
Age
From 6 months old to 30 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a sealed envelope
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
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.MUMS.fm.REC.1397.379
Health conditions studied
1
Description of health condition studied
Breath Holding Spells
ICD-10 code
R06.89
ICD-10 code description
Other abnormalities of breathing
Primary outcomes
1
Description
The number of Breath Holding Spells in a month
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the consumtion
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: BHS Children are given 1 or 2 CCfluoxetine syrup with iron drop for 3 month each morning after breakfast . The fluoxetine syrup used in this study was purchased from Abidi Company, which contains 10 mg of active substance per 10 cc. Usual consumption is 10 doses per day.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only a drop of iron is given to BHS children for 3 months each morning after breakfast.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Farah Ashrafzadeh
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2753
Email
ashrafzadehf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
ramresearch@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
Zahra Farzadfard
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2753
Email
sz.farzadfard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farah Ashrafzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmad abad AVE, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2770
Email
ashrafzadehf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farah Ashrafzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2770
Email
ashrafzadehf@mums.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