1. Home
  2. Approved trials
  3. » فارسی

comparison of surfactant injection through tracheal in neonates with respiratory distress syndrome

Protocol summary

Summary
Objective: to determine therapeutic effect of surfactant injection through tracheal in hospitalized newborn infants with respiratory distress syndrome in Amiralmomenin hospital in Semnan. Study design: non-randomized, Parallel-group, and without placebo. single-center. Inclusion criteria: premature infants admitted to the neonatal intensive care unit with a definite diagnosis of respiratory distress syndrome, age ≤ 24 hours. Exclusion criteria: infants with major abnormalities, chromosomal abnormalities, severe asphyxia, need to intubation at birth. Statistical population: all newborns with respiratory distress syndrome. Method of execution: surfactants administration via endotracheal tube. Clinical Guide of surfactants administration will be accordance to Aguar and colleagues study in 2014. Data collecting tool: 1. gestational age, gender, singleton or multiple pregnancy, maternal risk factors, birth weight, birth length and head circumference at birth, method of delivery, one and five-minute Apgar birth number, receiving cortons before birth by mothers and analysis of blood gases arterial at first hour of birth 2. Check list of data records based on RDS score, intensity of respiratory distress based on the X-ray, neonatal mechanical ventilation, surfactant dosage, age of prescribed surfactant (h), length of stay, patient outcomes (death / improvement) , Complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080825732N8
Registration date: 2017-01-16, 1395/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-16, 1395/10/27
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of surfactant injection through tracheal in neonates with respiratory distress syndrome
Public title
comparison of therapeutic effect of surfactant injection through tracheal in neonates with respiratory distress syndrome hospitalized in Amir al-momenin Hospital in Semnan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premature infants admitted to the neonatal intensive care unit with definitive diagnosis of RDS by pediatrician using clinical symtoms including tachypnea, intercostal retraction, nasal flaring, cyanosis, and hypotension and respiratory arrest. Exclusion criteria: infants with major abnormalities, chromosomal abnormalities, severe asphyxia, and need to Antvbyshn at birth.
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: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences, Deputy of research and technology, Ethics Committee
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
IR.SEMUMS.REC.1395.14

Health conditions studied

1

Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Severity of respiratory distress
Timepoint
Before starting study and one hour after Following Prescribing Dosing surfactant
Method of measurement
Based on radiography

2

Description
Apgar score
Timepoint
minute one and five Birth
Method of measurement
View Information registered records Filed in the labor

Secondary outcomes

1

Description
Severity of respiratory distress
Timepoint
After injecting surfactant
Method of measurement
Based on Picture Radiography

Intervention groups

1

Description
Intervention group: Surfactant injection (Prescribed according to the instructions the manufacturer and section stock) to method of INSURE for all neonates with respiratory distress syndrome (RDS) hospitalized in the neonatal intensive care unit Amiralmomenin hospital, Semnan.
Category
Treatment - Drugs

2

Description
In control group, no intervention was performed and were assessed only for comparison of two groups of the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital AmirAlMomenin Semnan
Full name of responsible person
Dr Shamsollah Noripour
Street address
Hospital AmirAlMomenin, Mostafa Khomeini Blvd, Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Dr Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Dr Shamsollah Nouripour
Position
Pediatrician
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Blvd Mostafa Khomeini, Semnan
City
Semnan
Postal code
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Shamsollah Nouripour
Position
Pediatrician
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Blvd Mostafa Khomeini, Semnan
City
Semnan
Postal code
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Shamsollah Nouripour
Position
Pediatrician
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Blvd Mostafa Khomeini, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.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
Loading...