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Investigation of the effects of nebulized ventolin in transient tachypnea of newborn

Protocol summary

Summary
Introduction:To date there is no effective drug therapy for Transient tachypnea of newborns(TNN) and respiratory support such as positive pressure and mechanical ventilation is used for these babies.Since salbutamol like β2- adrenergic in this regard,were used only in one study (Myo - jing) and in some cases,show positive effect and no side effects in treatment of TTN ,So this clinical trial was designed.Method: In a double-blind randomized clinical trial we evaluate the effect of nebulized salbutamol in neonates with TTN."Term/near term neonates with TTN" without "Sepsis" ," pneumonia" ,"congenital heart disease" ," Pulmonary hypertension" included and "preterm neonate s with Respiratory distress syndrome" ,"pneumonia" ,"sepsis" , "surfactant requirement" excluded from study and divided into two groups to get: one dose of nebulized saline 0.9% (placebo) or nebulized salbutamol.To evaluate the efficacy of any of the treatments used, we determine amount and duration of tachypnea, duration of oxygen therapy, continuous positive airway pressure or the necessity to use the ventilator in each group

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016010225811N1
Registration date: 2016-03-18, 1394/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Mirhadi Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2094
Email address
drmussavihadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of nebulized ventolin in transient tachypnea of newborn
Public title
Investigation of the effects of nebulized ventolin and saline .%9 in transient respiratory distress of newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Term/near term neonates with transient tachypnea of newborn; without Sepsis; pneumonia; congenital heart disease; Pulmonary hypertension. Exclusion criteria: Preterm neonates with Respiratory distress syndrome; pneumonia; sepsis; surfactant requirement.
Age
From 1 day old to 1 day old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences
Street address
Av.Azadi, Av.Golgasht
City
Tabriz
Postal code
65423987456
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
TBZMED.REC.1394.701

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
Admission durations
Timepoint
during study and drug injection every 6 hour
Method of measurement
days

2

Description
CPAC application hours
Timepoint
primary 24 hours
Method of measurement
hour

3

Description
Mechanical ventilation application hours
Timepoint
primary 24 hours
Method of measurement
hour

Secondary outcomes

1

Description
Arrhymia
Timepoint
during study
Method of measurement
cardiac monitor

Intervention groups

1

Description
Intervention group: Salbutamol Glasco Compani product ./1 mg/kg with 2 milliliter saline nebulization /6 hour for 24 hours
Category
Treatment - Drugs

2

Description
Control group: 2 milliliter saline nebulizationGhazi pharmaceutical company/6 hour for 24 hours
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal intensive care unite,Talegani Hospital
Full name of responsible person
Dr Mirhadi Mousavi
Street address
Av.Azadi , Av.Golgast
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Av.Azadi , Av.Golgast
City
Tabriz
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,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mousavi Mirhadi
Position
Neonatologist
Other areas of specialty/work
Street address
Pediatric Hospital,Tabriz
City
Tabriz
Postal code
Phone
+98 41133272094
Fax
Email
drmussavihadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mousavi Mirhadi
Position
Neonatologist
Other areas of specialty/work
Street address
Tabriz Pediatrics Hospital
City
Tabriz
Postal code
Phone
+98 41133272094
Fax
Email
drmussavihadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mousavi Mirhadi
Position
Neonatologist
Other areas of specialty/work
Street address
Tabriz Pediatrics Hospital
City
Tabriz
Postal code
Phone
+98 41133272094
Fax
Email
Drmussavihadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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