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Comparing the efficacy of Albuterol Nebulizer and Albuterol plus Budesonide Nebulizer in treatment of Respiratory Distress Syndrome

Protocol summary

Summary
The aim of this randomized clinical trial is to compare the efficacy of Albuterol Nebulizer and Albuterol plus Budesonide Nebulizer in treatment of infants' Respiratory Distress Syndrome. The Target population is 60 infants. Preterm infants with respiratory distress syndrome admitted in NICU ward of our hospital will be assessed for eligibility.infants with birth weight between 1000-2500 gr,Gestational age of less than 36 weeks, Mechanical ventilation for at least two days and Oxygen saturation of more than 30% after extubation will be included in the study. Patients with Hemorrhagic lesions, Congenital Anomalies, Chromosomal Anomalies, early sepsis and death before 72 hours of age will be excluded from the study.Patients will be randomly allocated to two groups; first group will receive 0.5 mg/kg of Albuterol Nebulizer (every 8 hours) and second group will receive Albuterol plus Budesonide Nebulizer (400 mcg/kg) every 12 hours for 3 to 5 days. Main outcome measures including respiratory rates, arterial oxygen saturation, distress and retraction and need for repeated intubation will be evaluated for assessing efficacy of treatment. Oxygen dependency, blood pressure, blood sugar, pneumonia, sepsis, pneumothorax and other adverse effects and complications will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111617413N22
Registration date: 2016-11-26, 1395/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Pharmaceutical Sciences Branch, Islamic Azad University
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Albuterol Nebulizer and Albuterol plus Budesonide Nebulizer in treatment of Respiratory Distress Syndrome
Public title
Comparing the efficacy of Albuterol Nebulizer and Albuterol plus Budesonide Nebulizer in treatment of Respiratory Distress Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: birth weight between 1000-2500 gr; gestational age of less than 36 weeks; mechanical ventilation for at least two days; oxygen saturation of more than 30% after extubation; pH<7.2; PCO2>55; PaO2<50. Exclusion criteria: hemorrhagic lesions; congenital anomalies; chromosomal anomalies; early sepsis; death before 72 hours of age.
Age
To 1 month old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
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
Committee on research ethics, pharmaceutical sciences branch, Islamic Azad University
Street address
Yakhchal st., Gholhak, Shariati st., Tehran, Iran
City
Tehran
Postal code
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
IR.IAU.PS.REC.1394.28

Health conditions studied

1

Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
pH
Timepoint
before and after intervention
Method of measurement
Arterial Blood Gas Assessment

2

Description
Respiratory rate
Timepoint
before and after intervention
Method of measurement
one minute counting by nurse

3

Description
Blood Pressure
Timepoint
before and after intervention
Method of measurement
Monitoring System

4

Description
Oxygen Saturation
Timepoint
before and after intervention
Method of measurement
Pulse Oxymetry

Secondary outcomes

empty

Intervention groups

1

Description
The second group will undergo treatment with inhaler Albuterol plus Budesonide through jet nebulizer (400 mcg every 12 hours) for 3 to 5 days.
Category
Treatment - Drugs

2

Description
First group will undergo treatment with Albuterol Nebulizer 0.5 mg/kg every 8 hours for 3 to 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Najmiyeh Hospital
Full name of responsible person
Bita Najafian
Street address
Hafez, Jomhouri st., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Pharmaceutical Sciences Branch, Islamic Azad University
Full name of responsible person
Farshaad Hashemian
Street address
Yakhchal st, Gholhak, Shariati st., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Pharmaceutical Sciences Branch, Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary-General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
dr.mhkhosravi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Pediatrics, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran,
Full name of responsible person
Bita Najafian
Position
Neonatalogist
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
bitanajafian@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of medical sciences, Tehran, Iran.
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary-General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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