Clinical trial on the effectiveness of surfactant administration via a thin intratracheal catheter (Insure method) and intubation during spontaneous breathing in premature neonates.
Objective: To compare the effectiveness of surfactant administration via a thin intratracheal catheter (Insure method) and intubation during spontaneous breathing in premature neonates.
Design: A single-blinded, block randomized clinical trial.
Study population: Premature infants with the respiratory distress syndrome.
Inclusion criteria: Premature infants with the respiratory distress syndrome; premature birth less than 32 weeks of gestational age; birth weight less than 1500 g.
Exclusion criteria: Congenital anomalies; requiring mechanical ventilation after birth; infants with underlying disease (congenital infections, asphyxia, congenital cardiac defect).
Sample size: 40 cases.
Study intervention: The intervention group is receiving 100 mg/kg surfactant in 1-3 minutes via a thin intratracheal catheter (Insure method) during spontaneous breathing. The control group is receiving surfactant via intubation by positive pressure ventilation with the same dosage.
Study outcome: To compare the effectiveness of two methods on duration of mechanical ventilation and morbidity and mortality rate in premature neonates 24 hours after intervention in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061328422N1
Registration date:2016-06-20, 1395/03/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Reza Gharaei
Name of organization / entity
Emam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
gharaeijr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the effectiveness of surfactant administration via a thin intratracheal catheter (Insure method) and intubation during spontaneous breathing in premature neonates.
Public title
Treatment of premature infants during spontaneous breathing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Premature infants with the respiratory distress syndrome; premature birth less than 32 weeks of gestational age; birth weight less than 1500 g.
Exclusion criteria: Congenital anomalies; requiring mechanical ventilation after birth; infants with underlying disease (congenital infections, asphyxia, congenital cardiac defect).
Age
From 1 day old to 1 day old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2013-10-19, 1392/07/27
Ethics committee reference number
IR.MUMS.REC.1392.163
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
Duration of mechanical ventilation
Timepoint
24 hours after intervention
Method of measurement
Day
Secondary outcomes
1
Description
Morbidity and mortality rate in premature neonates
Timepoint
24 hours after intervention
Method of measurement
Case
Intervention groups
1
Description
Control group: Neonatal intubation and who are receiving100 mg/kg surfactants in 1-3 minutes via feeding tube.
Category
Treatment - Drugs
2
Description
Intervention group: Who are receiving 100 mg/kg surfactant in 1-3 minutes from a feeding tube via a thin intratracheal catheter (Insure method) during spontaneous breathing.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Reza Gharaei
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
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, Mashhad 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
Emam Reza Hospital
Full name of responsible person
Hassan Boskabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3852 1121
Fax
Email
BoskabadiH@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
Hassan Boskabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3852 1121
Fax
Email
BoskabadiH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
Reza Gharaei
Position
neonatologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
gharaeijr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)