Objectives: To assess the effect of inhaler salbutamol versus placebo on treatment of neonatal transient tachypnea.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible neonates with transient tachypnea who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 34 to 47 weeks; neonatal transient tachypnea.
Exclusion criteria: Pneumothorax; maternal addiction; respiratory distress syndrome; meconium aspiration; pneumonia; sepsis; congenital heart disease; pulmonary hypertension.
Intervention group: 0.1 ml/kg salbutamol and 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized.
Control group: 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized.
Primary outcome: (a) number of breathing before and 0.5, 1 and 4 hours after treatment by physical examination; (b) TTN clinical score before and 0.5, 1 and 4 hours after treatment by physical examination; (c) arterial oxygen saturation before and 4 hours after treatment by checking arterial blood sample.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711139014N201
Registration date:2017-11-15, 1396/08/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-15, 1396/08/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhaler salbutamol versus placebo on treatment of neonatal transient tachypnea: a double blind randomized clinical trial
Public title
Effect of inhaler salbutamol versus placebo on treatment of neonatal transient tachypnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 34 to 47 weeks; neonatal transient tachypnea.
Exclusion criteria: Pneumothorax; maternal addiction; respiratory distress syndrome; meconium aspiration; pneumonia; sepsis; congenital heart disease; pulmonary hypertension.
Age
From 8 months old to 11 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.UMSHA.REC.1396.531
Health conditions studied
1
Description of health condition studied
Neonatal transient tachypnea
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnoea of newborn
Primary outcomes
1
Description
Number of breathing
Timepoint
Before and 0.5, 1 and 4 hours after treatment
Method of measurement
By physical examination
2
Description
TTN clinical score
Timepoint
Before and 0.5, 1 and 4 hours after treatment
Method of measurement
By physical examination
3
Description
Arterial oxygen saturation
Timepoint
Before and 4 hours after treatment
Method of measurement
By checking arterial blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.1 ml/kg salbutamol and 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized.
Category
Treatment - Drugs
2
Description
Control group: 2 ml normal saline 0.9% plus 5 to 6 l/min oxygen for 20 min will be nebulized.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Nishtman Sadeghi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan University of Medical Sciences
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
Fatemieh Hospital
Full name of responsible person
Dr Nishtman Sadeghi
Position
Pediatrician
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
nishti_sadeghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Behnaz Basiri
Position
Neonatologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
b.basiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)