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the study of Inhaled Salbutamol Influence on the Outcome of Transient Tachypnea of the Newborn in the imam khomeini hospital

Protocol summary

Summary
Aim of study: The aim of this study was to evaluate the effect of oral administration of salbutamol on the clinical course of TTN. Design of study: In this single center clinical trial study, 148 patients with TTN were randomly divided into two groups. Inclusion criteria included: tachypnea (RR> 60) during the first 6 hours of birth, continuity of tachypnea for at least 12 hours and the CXR view, and exclusion criteria included neonates with congenital anomalies, proven systemic infection (positive blood culture), meconium aspiration, respiratory distress syndrome (based on the graph), intrauterine growth retardation, history of fetal distress, pneumonitis, congenital heart disease, DIC, multi organ failure, hypocalcemia, hypoglycemia and polycythemia. Subotomol and normal saline (placebo) were administered in the intervention and control groups, respectively. Medication of newborns start at 6 birthday (up to 72 hours after starting treatment). Respiratory rate, heart rate, FIO2, O2 saturation were measured at 30 minutes, 1 and 4 hours after each intervention, To evaluate the response to salbutamol anesthetic.The results of the study were compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062129336N3
Registration date: 2017-07-22, 1396/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-22, 1396/04/31
Registrant information
Name
Arash Malakian
Name of organization / entity
Ahvaz Jundishappoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7370
Email address
malakian-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor research of Ahvaz Jundishapur University of Medical sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the study of Inhaled Salbutamol Influence on the Outcome of Transient Tachypnea of the Newborn in the imam khomeini hospital
Public title
Influence of Inhaled Salbutamol on the Outcome of Transient Tachypnea of the Newborn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Rawlings and Smith's criteria include: 1) Tachypnea (RR> 60) during the first 6 hours of birth 2) Continuity of tachypnea for at least 12 hours 3) The CXR view consists of at least one of the following: elevation of the central vessels of the lung, increasing the thickness of the lobes between the lobes due to fluid accumulation, congestion of the navel of both lungs, airy lung, ie flattening of the diaphragm or enlargement of the anterior posterior chest or both Exclusion criteria: 1) Neonates with congenital anomalies 2) Proven systemic infection (positive blood culture) 3) Meconium aspiration 4) Respiratory distress syndrome (based on the graph) 5) Intrauterine growth retardation 6) history of fetal distress, pneumonitis, congenital heart disease, DIC, multi organ failure, hypocalcemia, hypoglycemia and polycythemia
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishaour University of Medical Sciences
Street address
Khuzestan, Ahvaz, Golestan, Ahvaz Jundishaour University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2015-02-21, 1393/12/02
Ethics committee reference number
ajums.REC.1393.390

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
Breathing rate
Timepoint
30 min, 1 and 4 h after Intervention
Method of measurement
Number of breaths per minute

2

Description
heart beat
Timepoint
30 min, 1 and 4 h after Intervention
Method of measurement
heart beat per minute

3

Description
Fraction of inspired oxygen
Timepoint
30 min, 1 and 4 h after Intervention
Method of measurement
FIO2 %

4

Description
o2 saturation
Timepoint
30 min, 1 and 4 h after Intervention
Method of measurement
Pulse oximetry

Secondary outcomes

1

Description
glucose
Timepoint
12 h after intervention
Method of measurement
blood test

2

Description
potassium
Timepoint
12 h after intervention
Method of measurement
blood test

3

Description
Arterial blood gas
Timepoint
12 h after intervention
Method of measurement
blood test

Intervention groups

1

Description
Intervention group: Salbutamol was administered in the intervention group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The medication was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the salbutamol was prescribed every 6 hours, for 72 hours after starting treatment. The dose of Salbutamol was 0.15 mg / kg body weight. If patient needed ventilator during treatment, intervention was stopped.
Category
Treatment - Drugs

2

Description
Control group: Normal saline (placebo) was administered in the control group. The solution was administered as an inhaler and through a nebulizer jet with an oxygen flow rate of 6-5 liters per minute.The intervention was taken at 20 minutes each intervention. If the respiratory distress continued and oxygen was needed, the normal saline was prescribed every 6 hours, for 72 hours after starting treatment. If patient needed ventilator during treatment, intervention was stopped.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Dr Arash Malakian
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Arash Malakian
Position
Faculty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6501
Fax
Email
malakian-a@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Arash Malakian
Position
Faculty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6501
Fax
Email
malakian-a@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Arash Malakian
Position
Faculty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6501
Fax
Email
malakian-a@ajums.ac.ir
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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