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Comparison of Ventolin nebulizer with supportive treatment in Transient tachypnea of the newborns (TTN) admitted to the neonatal intensive care unit (NICU) of Imam Khomeini and Bouali Sari hospitals of Sari

Protocol summary

Study aim
The aim of this study is to compare Ventolin nebulizer with supportive treatment in transient respiratory rate of newborns and different intensities of their respiratory distress
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 0 on 60 patients randomized by Stratified Permuted Block Randomization method with blocks of 4
Settings and conduct
This double-blind randomized clinical trial is conducted in infants with TTN hospitalized in the NICU of Imam and Boali Hospitals of Sari. Patients are randomly selected by the Stratified Permuted Block Randomization method with blocks of 4 and divided into two intervention and control groups in parallel. Patients and nurses will not know about the allocation of patients to study groups.
Participants/Inclusion and exclusion criteria
Neonates with gestational age >34 weeks who meet the criteria for TTN are included in the study. In case of meconium aspiration, pneumonia, complex Coronary heart disease (CHD), Tachycardia above 180, Silverman Anderson score less than 46, Ventilator therapy since birth, diagnosis of RDS during hospitalization and administration of surfactant, they are excluded.
Intervention groups
In the intervention group, 0.1 mL of salbutamol (Ventolin, salbutamol sulfate 5 mg/mL) is nebulized in 3 mL of 0.9% normal saline. The standard dose of salbutamol is 0.15 mg/kg/dose. It will be nebulized every day with a jet-type nebulizer with a continuous oxygen flow of 5 liters per minute during a 10-minute period and every 6 hours for a day. In the control group, they will receive 2 mL of 0.9% saline as a nebulizer.
Main outcome variables
Primary outcomes: duration of initial CPAP and oxygen therapy; O2 and CO2 after nebulizer; Hospitalization days; Time to start feeding based on Silverman Anderson score l<4; stabilization of heart rate, breathing and Spo2; Absence of abdominal distension

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091201002801N6
Registration date: 2023-07-23, 1402/05/01
Registration timing: registered_while_recruiting

Last update: 2023-07-23, 1402/05/01
Update count: 0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Roya Farhadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3018
Email address
rfarhadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ventolin nebulizer with supportive treatment in Transient tachypnea of the newborns (TTN) admitted to the neonatal intensive care unit (NICU) of Imam Khomeini and Bouali Sari hospitals of Sari
Public title
Comparison of Ventolin nebulizer with supportive treatment in Transient tachypnea of the newborns (TTN) admitted to the neonatal intensive care unit (NICU) of Imam Khomeini and Bouali Sari hospitals of Sari
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with gestational age more than 34 weeks Tachypnea with or without cyanosis Respiratory distress Chest X-ray findings in favor of TTN
Exclusion criteria:
Meconium aspiration Other diseases in the radiography such as pneumonia and... Complex Coronary heart disease (CHD) Tachycardia above 180 Silverman Anderson score less than 46 Ventilator therapy since birth Diagnosis of RDS during hospitalization Administration of surfactant with diagnosis of RDS
Age
From 1 year old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients into two treatment groups will be by Stratified Permuted Block Randomization method with blocks of 4. First the patients are divided into two groups based on the severity of TTN, then in each group, using Block Randomization, the patients will receive one of the interventions. To generate random allocation, the sealed envelope site was used, which created the a random table with the code 105487821465911 for us, which shows how patients enter the two intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurse and the study participants do not know who is in which group. Placebo and drug have the same color and shape in appearance and are coded by the researcher and each patient will be given a drug code. Then the mediation is given to the nurse and nebulized.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for Research, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4712855689
Approval date
2023-07-12, 1402/04/21
Ethics committee reference number
IR.MAZUMS.REC.1402.166

Health conditions studied

1

Description of health condition studied
Transient tachypnea of newborn
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnea of newborn

Primary outcomes

1

Description
Primary CPAP (continuous positive airway pressure) duration
Timepoint
Time interval from start to end of CPAP
Method of measurement
Minute and hour

2

Description
Oxigen therapy duration
Timepoint
Time interval from start to end of Oxigen therapy
Method of measurement
Minute and hour

3

Description
Hospitalization length
Timepoint
Time from hospitalization to discharge
Method of measurement
Day

4

Description
Time to start feeding based on Silverman Anderson score less than 4
Timepoint
Time to start feeding in day
Method of measurement
Calendar

5

Description
Stabilization of respiratory rate and heart rate
Timepoint
Calculate the stabilization time of respiratory rate and heart rate
Method of measurement
Hour

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 0.1 mL of salbutamol (Ventolin, salbutamol sulfate 5 mg/mL) is nebulized in 3 mL of 0.9% normal saline. The standard dose of salbutamol is 0.15 mg/kg/dose. It will be nebulized every day with a jet-type nebulizer with a continuous oxygen flow of 5 liters per minute during a 10-minute period and every 6 hours for a day
Category
Treatment - Drugs

2

Description
Control group: In the control group, they will receive 2 mL of 0.9% saline as a nebulizer.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bouali Sina Hospital of Sari
Full name of responsible person
Roya Farhadi
Street address
Bouali Hospital, Pasdaran Boulevard
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Roya Farhadi
Street address
Imam Hospital, Amir Mazandarani Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3010
Email
rfarhadi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4712855689
Phone
+98 11 3448 4800
Email
pebrahimnejad@mazums.ac.ir
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Maedeh Gouran
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
ساری بلوار پاسداران بیمارستان بوعلی، مرکز تحقیقات عفونی اطفال
City
ساری
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Fax
Email
maedeh.gooran@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Booali hospital. Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Booali hospital. Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Fax
+98 11 3334 4506
Email
rfarhadi@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Contact Dr. Roya Farhadi
When the data will become available and for how long
Informations will send within few days after the email.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Contact Dr. Roya Farhadi
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
Informations will send within few days after the email.
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