Determining the effect of nebulized salbutamol versus nebulized epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Sealed envelopes were used for randomization.
Settings and conduct
Infants diagnosed with transient tachypnea will be evaluated in the neonatal intensive care unit in Al-Zahra hospital of Tabriz city. The clinical expert evaluating the results of the study and the person analyzing the study data are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria were transient tachypnea of neonates and admission at neonatal intensive care unit. Neonates with first minute apgar below 4, respiratory distress syndrome caused by surfactant deficiency, congenital anomalies, syndromes of chromosomal disorders, congenital heart diseases, premature neonatal sepsis, meconium aspiration and infants with metabolic disorders will excluded.
Intervention groups
Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants. Intervention group 2: In the epinephrine group, 0.5 ml per kilogram of the infants weight will be prescribed from a 1 mg/ml ampoule of epinephrine. Control group: 2 ml of normal saline will be nebulized.
Main outcome variables
Respiratory rate, Heart rate, Oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221028056324N1
Registration date:2023-09-09, 1402/06/18
Registration timing:registered_while_recruiting
Last update:2023-09-09, 1402/06/18
Update count:1
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Nazila Khanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 0108
Email address
lotfalinezhadm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-29, 1402/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nebulized Salbutamol versus nebulized Epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit
Public title
Effect of nebulized Salbutamol versus Epinephrine in treatment of transient tachypnea of neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Transient tachypnea of neonates
Neonatal intensive care unit
Exclusion criteria:
First minute apgar below 4
Respiratory distress syndrome caused by surfactant deficiency
Congenital anomalies
Syndromes of chromosomal disorders
Congenital heart diseases
Premature neonatal sepsis
Meconium aspiration
Infants with metabolic disorders
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the study groups will be done using a sealed envelope. Patients will be evaluated in three groups including intervention group 1, intervention group 2 and control group. 90 envelopes in three groups of A, B or C will prepared (30 each) and sealed. Then when the patients arrive at the neonatal intensive care unit, the envelopes are opened by the nurse delivering the patient and The grouping will be written as A, B or C on the clinical file. Then, according to the desired group, the intervention will be prescribed for the patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The specialist that evaluating the final effect of the intervention and possible complications as well as the person analyzing the data will be blinded to the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Mardaniazar Hospital, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.TBZMED.REC.1401.601
Health conditions studied
1
Description of health condition studied
Transient Tachypnea of Neonates
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnea of newborn
Primary outcomes
1
Description
Respiratory rate
Timepoint
Half an hour, one hour and four hours after nebulizer administration
Method of measurement
Physical examination
2
Description
Heart rate
Timepoint
Half an hour, one hour and four hours after nebulizer administration
Method of measurement
Noninvasive pulsoxymetry
3
Description
Oxygen saturation
Timepoint
Half an hour, one hour and four hours after nebulizer administration
Method of measurement
Noninvasive pulsoxymetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the epinephrine group, 0.5 ml per kilogram of the infants weight will be prescribed from a 1 mg/ml ampoule of epinephrine.
Category
Treatment - Drugs
3
Description
Control group: 2 ml of normal saline will be nebulized.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mardaniazar hospital
Full name of responsible person
Nazila Khanzadeh
Street address
Mardaniazar Hospital, Khavaran Town
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Phone
+98 41 3159 5090
Email
mardaniazar@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
3rd Floor, Central building, Faculty of medicine, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee.
What processes are involved for a request to access data/document
Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee.