This study will be done with the aim of investigation the effectiveness of inhaled salbutamol in the treatment of transient tachypnea of the newborn. This study is one blinded clinical trial. The study population will be included infants hospitalized in intensive care unit of Imam Reza Hospital. 80 newborns will be selected in available method and will be randomly assigned into two intervention and control groups. The intervention group will receive an inhaled salbutamol with dose of 0.15mg that is equal to 0.15ml per kilogram of body weight by nebulizer for 20 minutes. The control group will receive normal saline solution 0.9% equal to 0.15 ml per kg body weight by nebulizer for 20 minutes. Before and after treatment, at intervals of 30 minutes, one and four hours after the start of treatment, the number of respiration, heart rate, oxygen saturation, oxygen consumption, respiratory distress score, and hospitalization time is recorded in the checklist and two groups are compared
Inclusion criteria: Neonates with term of gestational age; Near term or after term; Having clinical symptoms and biographies in favor of TTN diagnosis; Having at least one of the radiographic TTN criteria (including hyperinflation, the presence of fluid in the transverse Fisher, etc).
Exclusion criteria: Meconium aspiration history; Respiratory distress syndrome; Congenital pneumonia; Polycysthemia; Hypoglycemia; Prolonged early sepsis; Cardiovascular disease; Tachycardia greater than 180 beats per minute; Cardiac arrhythmia; Congenital anomaly
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081414333N80
Registration date:2017-08-29, 1396/06/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-29, 1396/06/07
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of inhaled salbutamol in the treatment of transient tachypnea of the newborn
Public title
Investigation the effectiveness and non effectiveness of inhaled salbutamol in the treatment of respiratory diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with term of gestational age; Near term or after term; Having clinical symptoms and biographies in favor of TTN diagnosis; Having at least one of the radiographic TTN criteria (including hyperinflation, the presence of fluid in the transverse Fisher, etc).
Exclusion criteria: Meconium aspiration history; Respiratory distress syndrome; Congenital pneumonia; Polycysthemia; Hypoglycemia; Prolonged early sepsis; Cardiovascular disease; Tachycardia greater than 180 beats per minute; Cardiac arrhythmia; Congenital anomaly
Age
From 1 day old to 2 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
kums.rec.1396.80
Health conditions studied
1
Description of health condition studied
Transient tachypnoea of newborn
ICD-10 code
p22.1
ICD-10 code description
Transient tachypnoea of newborn
Primary outcomes
1
Description
Number of breaths
Timepoint
Before starting treatment and after treatment at intervals: 30 minutes, one and four hours after the start
Method of measurement
By physician based on the number of breaths per minute
2
Description
Percent saturation of oxygen
Timepoint
Before starting treatment and after treatment at intervals: 30 minutes, one and four hours after the start
Method of measurement
By pulse oximetry
3
Description
Heart rate
Timepoint
Before starting treatment and after treatment at intervals: 30 minutes, one and four hours after the start
Method of measurement
By pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive an inhaled salbutamol with dose of 0.15mg that is equal to 0.15ml per kilogram of body weight by nebulizer for 20 minutes.
Category
Treatment - Drugs
2
Description
The control group will receive normal saline solution 0.9% equal to 0.15 ml per kg body weight by nebulizer for 20 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Shohreh Dabiri
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shohreh Dabiri
Position
Resident of children
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
Dr.dabiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homa Babaei
Position
Professor of Infants
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
HOMA_BABAEI@KUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shohreh Dabiri
Position
Resident of children
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6300
Fax
Email
Dr.dabiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)