Comparison of effectiveness of surfactant administration via endotracheal tube and thin endotracheal catheter in neonates with respiratory distress syndrom
The aim of this study was to determine and compare effectiveness of surfactant administration via endotracheal tube and thin endotracheal catheter in neonates with respiratory distress. This study is a single-blind, double-blind, clinical trial. 105 patients with acute respiratory distress referring to the Shahrekord Neonatal ward with Inclusion criteria: RDS clinical symptoms include respiratory distress; tachypnea. Exclusion criteria: major anomalies; mother curioamniotic history; early sepsis; need to continue mechanical ventilation immediately after injection of surfactant. They are randomly selected. Patients with respiratory distress are divided into two groups of 52 people. The first group is injected by intraperitoneal intubation with routin injection and in the second group, the injection of surfactant is performed using endotracheal tube (vascular tube). Patients are checked up to twenty-eight days later. The need for oxygen and the administration of surfactant respond to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102110222N16
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of surfactant administration via endotracheal tube and thin endotracheal catheter in neonates with respiratory distress syndrom
Public title
Comparison of effectiveness of surfactant administration via endotracheal tube and thin endotracheal catheter in neonates with respiratory distress.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: RDS clinical symptoms include respiratory distress; tachypnea.
Exclusion criteria: major anomalies; mother curioamniotic history; early sepsis; need to continue mechanical ventilation immediately after injection of surfactant.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani street
City
Shahrekord
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SKUMS.REC.1395.69
Health conditions studied
1
Description of health condition studied
Acute Respiratory Distress
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Frequency of administration of surfactant
Timepoint
Twenty eight later
Method of measurement
checklist
Secondary outcomes
1
Description
Duration of oxygen demand
Timepoint
Twenty eight day later
Method of measurement
checklist
Intervention groups
1
Description
The first group is injected by intraperitoneal intubation with routin injection
Category
Treatment - Drugs
2
Description
The second group, the injection of surfactant is performed using endotracheal tube (vascular tube)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Roya Choopani
Street address
Parastar street, Hajar Hospital of Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord University of Medical Sciences
City
Shahrekord
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, Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Pediatrician, Assistant professor
Other areas of specialty/work
Street address
Hajar Hospital, Pasdaran St.
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
choopani.r@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Roya Choopani
Position
Pediatrician, Assistant professor
Other areas of specialty/work
Street address
Hajar Hospital, Parastar street
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
choopani.r@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Roya Choopani
Position
Pediatrician, Assistant professor
Other areas of specialty/work
Street address
Hajar Hospital, Pasdaran St.
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
choopani.r@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)