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The effect of salbutamol in treatment of transient tachypnea of newborn

Protocol summary

Summary
In this study we will evaluate the effect of salbutamol nebulies in improving signs of transient tachypnea of newborn . This double blind, clinical controlled trial will be done on 70 late Preterm, term, post term neonate with transient tachypnea of newborn during first six hours after birth. The diagnosis of transient tachypnea of newborn will be according to clinical evidence of tachypnea (respiratory rate greater than 60 per minute) with or without respiratory distress, with at least one sign of radiologic finding of transient tachypnea of newborn on chest X Ray. The neonates will be divided randomly in two groups, to receive one dose of Salbutamol (Asthalin manufacture by CIPLA ,INDIA) 0.15 miligram, equal to; 0.15mililiter per kilogram of body weight (solution A) or 0.15 mililiter per kilogram of body weight %0.9 normal salin solution (solution B) by nebulizer, within 10 minutes. Before and after treatment in intervals of: 30 minute, one, four, six hours, the respiratory rate, heart rate, oxygen saturation, oxygen requirement, Retraction score (base on Silverman – Anderson Retraction score) and the time of first feeding and duration of hospitalization should be evaluated and recorded. The above data will be analyzed by SPSS statistical program software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062518232N1
Registration date: 2014-08-07, 1393/05/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-07, 1393/05/16
Registrant information
Name
Fatemeh Heydari
Name of organization / entity
Babol Medical Sciences Univercity
Country
Iran (Islamic Republic of)
Phone
+98 11 1324 2151
Email address
f.heydari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Babol University of Medical Sciences
Expected recruitment start date
2014-08-02, 1393/05/11
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of salbutamol in treatment of transient tachypnea of newborn
Public title
The effect of salbutamol in treatment of transient tachypnea of newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The late preterm (gestational age of 34 – 37 weeks) and term (gestational ageof 37 -42 weeks) and post term (gestational age greater than 42 weeks) neonates with tachypnea (Respiratory Rate greater than 60 per minute) with or without respiratory distress within 6 hours of birth. Exclusion criteria: Pretem neonates (gestational age less than 34 weeks); neonates with history of asphyxia; birth trauma; meconium aspiration syndrome; congenital pneumonia; a history of chorioamnionitis or corticosteroids therapy in mother; gross congenital anomaly and neonates with tachycardia; arythmia; blood culture or CRP positive during treatment will be excluded.
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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 Babol University of Medical Sciences
Street address
Ganjafrooze street
City
Babol
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
30/4026/ژ / پ

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
Tachypnea
Timepoint
before intervention; 30 minute, one, four, six hours later
Method of measurement
observation and record of respirtory rate per minute

Secondary outcomes

1

Description
Respiratory Rate
Timepoint
before intervention; 30 minute, one, four, six hours later
Method of measurement
Observation and record

2

Description
Hart beat
Timepoint
before intervention; 30 minute, one, four, six hours later
Method of measurement
Observation and record of heart beat per minute

3

Description
Time of start feeding
Timepoint
Before intervention; 30minute, one, four, six hours later
Method of measurement
hour

4

Description
O2 requirement
Timepoint
Before intervention; 30 minute, one, four, six hours later
Method of measurement
per liter. per minute

5

Description
Duration of hospitalization
Timepoint
day
Method of measurement
day

6

Description
Retraction Score
Timepoint
Before intervention ;30 minute, one, four, six hours later
Method of measurement
Oservation and record on bases of SILVERMAN - ANDERSON Retraction Score

7

Description
Arterial Blood Gases
Timepoint
before intervention, and after intervention if necessary
Method of measurement
Blood sample

8

Description
Oxygen saturation percent
Timepoint
before intervention; 30 minute, one, four, six hours later
Method of measurement
observation and recod of oxygen saturation (percent)

Intervention groups

1

Description
Intervention group : administration of one dose of Salbutamol (Asthalin, manufactured by CIPLA, INDIA) 0.15mililiter per kilogram of body weight, by nebulizer within 10 minutes.
Category
Treatment - Drugs

2

Description
control group : to receive one dose of 0 .15 mililiter per kilogram of body weight of 0.9 % normal salin by nebulizer, with in ten minute.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Aiatollah Rohani Hospital
Full name of responsible person
Heydari Fatemeh
Street address
Ganjafrooz street
City
Babol

2

Recruitment center
Name of recruitment center
Amirkola children's hospital
Full name of responsible person
Heydari Fatemeh
Street address
Amirkola
City
Babol

3

Recruitment center
Name of recruitment center
Babol Clinic
Full name of responsible person
Heydari Fatemeh
Street address
Seyyed jamaloddin Asadabady street, Baghferdose squer
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Moghadamnia Aliakbar
Street address
Babol University of Medical Sciences, Ganjafrooze street
City
Babol
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, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Heydari Fatemeh
Position
fellow of neonatology
Other areas of specialty/work
Street address
Amirkola childeren's hospital, Amirkola
City
Babol
Postal code
4731741151
Phone
+98 11 3235 2988
Fax
+98 11 3234 6963
Email
dr.fatmeh_heydari@yahoo.comf.heydari@mubabol.ac.ir pediatrics_amirkola@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Haghshenas Mohsen
Position
Assistent professor; Neonatologist
Other areas of specialty/work
Street address
Ayatollah Rohani hospital, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 3223 8290
Fax
Email
matia.mojaveri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Heydari Fatemeh
Position
fellow of neonatology
Other areas of specialty/work
Street address
Amirkola children's hospital, Amirkola
City
Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
f.heydari@mubabol.ac.ir dr.fatmeh_heydari@yahoo.com pediatrics_amirkola@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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