Comparison of inhaled salbutamol With placebo (water for inj.) as an add-therapies on the duration of stay of newborns and the Recovery process of tachypnea and o2 dependence in transient tachypnea of Newborns in NICU in Qom hospitals: a clinical trial study
The effect of inhaled salbutamol on the duration of stay of newborns, and the recovery of tachypnea and O2 dependence in newborns with transient tachypnea
Design
Randomized double-blind Clinical trials with a control group, with parallel groups.
Settings and conduct
60 newborns(diagnosed with TTN in the NICU department of hospitals in Qom province) with random allocation block method will be assigned into intervention and control groups. The intervention group received routine treatment with salbutamol and the control group received routine treatment with placebo (distilled water). In each group, the infants are placed in a nebulizer for 4 doses at12-hour intervals (10 minutes for each time) within 48 hours by NICU physicians and nurses, and examining the consequences by the physician at intervals of 30 minutes, one hour and 4 hours after The treatment will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy term infants with mild to moderate respiratory distress.
Exclusion criteria: multiple anomalies; severe infection; metabolic disease.
Intervention groups
Control group receiving placebo; intervention group receiving salbutamol inhaler
Main outcome variables
Clinical TTN score; respiratory rate; heart rate; NICU duration of stay; blood oxygen saturation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190503043457N1
Registration date:2019-05-28, 1398/03/07
Registration timing:retrospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Alireza saadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3665 1801
Email address
a.rsaadati@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of inhaled salbutamol With placebo (water for inj.) as an add-therapies on the duration of stay of newborns and the Recovery process of tachypnea and o2 dependence in transient tachypnea of Newborns in NICU in Qom hospitals: a clinical trial study
Public title
Comparison of inhaled salbutamol with placebo (water for inj.) on recovery process of newborns' transient tachypnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A healthy term newborn with mild to moderate respiratory distress
Exclusion criteria:
Multiple anomalies
Severe infection
Metabolic disease
Age
From 1 day old to 7 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A random block allocation method will be used. In this way, 11 blocks of four will be considered. Then, using the random number table for each block, one of the following conditions will be considered:
AABB, ABAB, ABBA, BBAA, BABA, BAAB.
Blinding (investigator's opinion)
Double blinded
Blinding description
Doctors and nurses and participants do not know who is in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No 83, alley 4, safashahr St.
City
Qom
Province
Ghoum
Postal code
0000000000
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.MUQ.REC.1397.205
Health conditions studied
1
Description of health condition studied
Transient tachypnea of Newborns
ICD-10 code
P22.1
ICD-10 code description
Transient tachypnoea of newborn
Primary outcomes
1
Description
Number of breaths
Timepoint
30 minutes, one and four hours after treat
Method of measurement
By physician based on the number of breaths per minute
2
Description
Percent saturation of oxygen
Timepoint
30 minutes, one and four hours after treat
Method of measurement
By pulse oximetry
3
Description
Heart rate
Timepoint
30 minutes, one and four hours after treat
Method of measurement
By pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving Salbutamol at a dose of 0.15 mg/kg body weight in 4 cc normal saline by nebulizer for 10 minutes
Category
Treatment - Drugs
2
Description
Control group: Receiving four cc distilled water by nebulizer for 10 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masoumeh Children Hospital
Full name of responsible person
Alireza saadati
Street address
Imam khomeini St
City
Qom
Province
Ghoum
Postal code
0000000000
Phone
+98 25 3665 1801
Email
a_saadati_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Qom university of medical sciences
Full name of responsible person
Hossein saghafi
Street address
Ghadir Blvd, After Park Boostan Ghadir, in front of Yadegar Imam Stadium, Complex Campus, Faculty of Medicine
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3197 1121
Email
dr.hosseinsaghafi@gmail.com
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 and technology, Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad mahmoudi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Masoumeh Children Hospital ,Imam khomeini St.
City
Qom
Province
Ghoum
Postal code
0000000000
Phone
+98 25 3665 1801
Email
u.hedayati@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza saadati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
neonatology
Street address
Masoumeh Children Hospital, Imam Khomeini st.
City
Qom
Province
Ghoum
Postal code
0000000000
Phone
+98 25 3665 1801
Email
a.rsaadati@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Alireza saadati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
neonatology
Street address
Masoumeh Children Hospital ,Imam Khomeini St.
City
Qom
Province
Ghoum
Postal code
0000000000
Phone
+98 25 3665 1801
Email
a.rsaadati@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available