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Evaluating the efficacy of airway clearance therapy (ACT) on short time outcome of cystic fibrosis patients in tabriz chlidren’s hospital

Protocol summary

Study aim
Evaluating the efficacy of airway clearance therapy on short time outcome of CF patients in tabriz chlidren hospital
Design
In this cross-sectional study,patients diagnosed with CF from 21/3/2017 to 21/3/2018, which range from 5to14 years old, and increased lung disease with FEV1=20-70%of the primary hospital admission spirometry will be included in the study and will be randomly divided into three groups
Settings and conduct
Patients in the case group, in addition to antibiotic therapy and conventional chest physiotherapy, were under NIV with BIPAP (NIV on days 2,4 and 6admitted for2 hours) and PEP (on the second day), Fourth and sixth admission for 30 minutes).The control group will be treated with antibiotic therapy and conventional chest physiotherapy. Ultimately, spirometry will be performed once per hospitalization and one day on discharge, and their differences will be compared with FEV1 and FVC The patients under study will be followed up within the next 6 months, and the frequency of exacerbation of the disease, the number of hospital admissions and the length of stay in the hospital will be compared
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with CF diagnosis,Patients aged 5 to 14 years,Patients with pulmonary disease with FEV1=20-70% in primary spirometry when admitted Exclusion criteria:Patients with reluctance to continue participating in the study,Patients who can not be traced to a cause such as death, transference to another city,etc.during the study period,Patients who do not have adequate compilation to continue treatment
Intervention groups
in the first and second group(case group),in addition to antibiotic therapy and conventional chest physiotherapy, were under NIV with BIPAP and PEP Fourth and sixth admission for 30minutes)
Main outcome variables
Forced expiratory volume in the first second, FEV1/FVC,peak expiratory flow

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131012014988N3
Registration date: 2018-04-26, 1397/02/06
Registration timing: retrospective

Last update: 2018-04-26, 1397/02/06
Update count: 0
Registration date
2018-04-26, 1397/02/06
Registrant information
Name
Mohammad Barzegar
Name of organization / entity
Pediatric Health Research Center,Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2265
Email address
phrc_mb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of airway clearance therapy (ACT) on short time outcome of cystic fibrosis patients in tabriz chlidren’s hospital
Public title
efficacy of airway clearance therapy (ACT) on short time outcome of cystic fibrosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients with CF diagnosis• Patients aged 5 to 14 years• Patients with exacerbation of lung disease with FEV1 = 20-70% in initial spirometry when admitted
Exclusion criteria:
• Patients with reluctance to continue participating in the study• Patients who can not be traced to a cause such as death, transference to another city, etc. during the study period.• Patients who do not have adequate compilation to continue treatment.
Age
From 5 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
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
Regional Ethics Committee, Office of the Vice Chancellor for Research, Tabriz University of Medical
Street address
تبریز-خیابان دانشگاه-ساختمان مرکزی شماره 2 دانشگاه علوم پزشکی تبریز- طبقه سوم-معاونت تحقیقات و فن آوری دانشگاه علوم پزشکی تبریز
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.827

Health conditions studied

1

Description of health condition studied
cystic fibrosis
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations

Primary outcomes

1

Description
Forced expiratory volume in the first second
Timepoint
In the second and last day of the admission
Method of measurement
By using spirometry device

2

Description
FEV1/FVC
Timepoint
In the second and last day of the admission
Method of measurement
By using spirometry device

3

Description
peak expiratory flow
Timepoint
In the second and last day of the admission
Method of measurement
By using peak flow-meter device

Secondary outcomes

1

Description
Number of Exacerebration within six months
Timepoint
within six months
Method of measurement
Cheklist

Intervention groups

1

Description
Intervention group: In addition to antibiotic therapy and conventional chest physiotherapy, patients underwent NIV with BIPAP (NIV on days 2, 4 and 6 admitted for 2 hours) and PEP (on the second, fourth and sixth days on admission for 30 minutes) Placed
Category
Treatment - Other

2

Description
Control group: The control group will be treated with antibiotics and conventional chest physiotherapy only. Ultimately, spirometry will be performed once per hospitalization and one day on discharge, and their differences will be compared with FEV1 and FVC.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz children hospital
Full name of responsible person
Nemat Bilan
Street address
خیابان ششگلان- مرکز آموزشی و درمانی کودکان
City
tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 41 3526 2250
Email
phrc_mb@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reasearch Deputy, Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Jouyban
Street address
Reasearch Deputy, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reasearch Deputy, Tabriz 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
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Nemat Bilan
Position
Pediatric pediatric pulmonologist, Professor, Faculty Member
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Health Research Center, Children Hospital, Sheshgelan street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Nemat Bilan
Position
Pediatric Pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
TABRIZ
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Masoomeh Ghasemour
Position
Pediatric polmunary fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
masoumeh_gh_a@yahoo.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
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
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