The effects of nebulized salbutamol on Transient Tachypnea of Neonates (TTN) treatment in Neonatal Intensive Care Unit (NICU) of Rajaei hospital of Tonekabon.
The effects of nebulized salbutamol on TTN treatment in NICU of Rajaei hospital of Tonekabon.
Design
This double blinded randomized clinical trial is aimed to assess the efficacy of nebulized salbutamol in neonates with transient tachypnea. 88 neonates are evaluated in this study. For block randomization www.sealedenvelope.com site is used.
Settings and conduct
This study is conducted in NICU department of Shahid Rajjaei Hospital of Tonekabon. Neonates with the diagnosis of TTN are randomly assigned to either groups and treated accordingly. Investigators, caregivers and data analysers are blinded to the treatments. Treatments are coded by a pharmacy technician and each patient is assigned to a unique code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Diagnosis of Transient Tachypnea of Neonates
Exclusion criteria:
1- Diagnosis of Respiratory Distress Syndrome
2-Sign of End-organ damage
3- Diagnosis of Sepsis
Intervention groups
In this study inhaled nebulized solution of salbutamol sulfate 0.1mL (5mg/mL) in 2 cc 0.9% saline is used in intervention group. In placebo group 2 cc 0.9% saline is used. All treatments are delivered in single dose through nebulizer.
Main outcome variables
TTN score 20 minutes and 6 hours after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170201032346N4
Registration date:2020-11-28, 1399/09/08
Registration timing:retrospective
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 91155226108
Email address
firoozihosein@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
The effects of nebulized salbutamol on Transient Tachypnea of Neonates (TTN) treatment in Neonatal Intensive Care Unit (NICU) of Rajaei hospital of Tonekabon.
Public title
The effects of nebulized salbutamol on transient tachypnea of neonates treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of TTN before 6 hour of birth according to Rawling and Smith criteria.
Exclusion criteria:
Diagnosis of respiratory distress syndrome
Presence of end-organ dysfunction
Sepsis Diagnosis
Age
To 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
participant are randomized with Distance randomization method. two groups of 44 patients are assigned to treatment or placebo group. each patient is assigned to a unique code provided by Distance randomization service from www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo are provided by the company producing the product. in terms of appearance drug and placebo are identical. Caregivers prescribe the drug. The research technician is assigned to lead two arms of study based on patient's assigned group. Caregivers, investigators and data analyser are blinded to the study groups.
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
Mazandaran University of Medical Sciences, Vice Chancellor of Research, Moalem st, Moalem sq, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MAZUMS.REC.95.2588
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
TTN score
Timepoint
20 minutes and 6 hours after treatment
Method of measurement
According to clinical severity criteria of transient tachypnea of neonates, disease is scored from 0 to 13. Higher score indicate more severe disease. The criteria includes: Expiratory grunting: None=0, Intermittent=1, Continuous=2. Supraclavicular Retraction: None=0, Mild=1, Moderate=2, Severe=3. Subcostal Retraction: None=0, Mild=1, Moderate=2, Severe=3. Cyanosis: None=0, Acral=1, Central=2. Nasal Flaring: None=0, Mild=1, Moderate=2, Severe=3.
2
Description
Heart rate
Timepoint
20 minutes and 6 hours after treatment
Method of measurement
Cardiac Monitoring. Beats per minutes
3
Description
Respiratory rate
Timepoint
20 minutes and 6 hours after treatment
Method of measurement
Cardiac Monitoring. cycle per minutes
4
Description
O2 Saturation
Timepoint
20 minutes and 6 hours after treatment
Method of measurement
Pulseoximeter, Percentage.
5
Description
Body temperature
Timepoint
20 minutes and 6 hours after treatment
Method of measurement
Thermometer. degree of Celsius.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inhalational 15mg/kg salbutamol (Ventolin Respiratory Solution, salbutamol sulfate 5 mg/mL) in 2 mL of 0.9 saline in a single dose is administered by nebulizer.
Category
Treatment - Drugs
2
Description
Control group: 2 cc of 0.9% saline is used in a single dose by nebulizer.