Comparison of the effect of minimally invasive surfactant therapy (MIST) vs Intubation, Surfactant administration and Extubation (INSURE) method in neonatal respiratory distress of preterm neonates with 34 weeks or less
(1) Objectives: comparison of the effect of two methods for injection of MIST vs INSURE in neonates with RDS (2) Design : 50 Preterm infants (28-34 weeks of gestation) born with respiratory distress syndrome in Arash Hospital were randomly allocated to two 25 groups to receive 200 mg/kg of surfactant using either the MIST or INSURE techniques (4) Participants including major eligibility criteria: Inclusion criteria: Preterm neonates between 28 to 37 weeks with RDS. Exclusion criteria: parents have not consent with incorporating in study; neonates with asphyxia (5) Intervention: 25 participants take 200 mg/kg surfactant by MIST method and another group receives same quantity of surfactant by INSURE method (6) Primary outcome:Duration of Oxygen Consumption, Apnea and Need for second dose surfactant and secondary outcome:The rate of intubated in First 72 h of Life, Length of Stay in NICU, Death and Complications of surfactant injection (Coughing or Gagging, Pneumothorax, Surfactant Reflux, Bradycardia, Pulmonary Hemorrhage, Intra ventricular Hemorrhage (>grade 2))
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080716937N4
Registration date:2017-07-27, 1396/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Zohreh Farsi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3284
Email address
mosayebi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-04-01, 1392/01/12
Expected recruitment end date
2014-02-28, 1392/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of minimally invasive surfactant therapy (MIST) vs Intubation, Surfactant administration and Extubation (INSURE) method in neonatal respiratory distress of preterm neonates with 34 weeks or less
Public title
Study of the effect of surfactant in respiratory distress of preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: preterm neonates with 34 week age or less; respiratory distress due to surfactant deficiency;
Exclusion criteria: parents have not consent with incorporating in study; neonate with asphyxia; neonates with intubation from the birth; respiratory distress not due to RDS; neonates with maternal abnormality
Age
To 1 month old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Randomization is done by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, Tehran, Tehran Province, Iran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
117813-9111403006
Health conditions studied
1
Description of health condition studied
Respiratory distress of newborn
ICD-10 code
p22.9
ICD-10 code description
Respiratory distress of newborn, unspecified
Primary outcomes
1
Description
Need for second dose surfactant
Timepoint
Per 6 hour after intervention
Method of measurement
Chart
2
Description
Apnea
Timepoint
During hospitalization
Method of measurement
Visit
3
Description
Duration of Oxygen Consumption
Timepoint
Per 6 hour after intervention
Method of measurement
Chart
Secondary outcomes
1
Description
Complications of surfactant injection (Coughing or Gagging, Pneumothorax, Surfactant Reflux, Bradycardia, Pulmonary Hemorrhage, Intra ventricular Hemorrhage (>grade 2))
Timepoint
Per 6 hour after intervention
Method of measurement
Chart and visit
2
Description
The rate of intubated in First 72 h of Life
Timepoint
Per 6 hour after intervention
Method of measurement
Chart
3
Description
Length of Stay in NICU
Timepoint
Per 6 hour after intervention
Method of measurement
Chart
4
Description
Death
Timepoint
During hospitalization
Method of measurement
Chart
Intervention groups
1
Description
participants take 200 mg/kg surfactant by MIST method
Category
Treatment - Drugs
2
Description
participants take 200 mg/kg surfactant by INSUR method
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Zohreh Farsi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohreh Farsi
Street address
Alley No169, St. Baghdarniya, Bagheri Highway, Resalat Highway
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences (Arash hospital)
Full name of responsible person
Zohreh Farsi
Position
neonatologist
Other areas of specialty/work
Street address
Alley No169, St. Baghdarniya, Bagheri Highway, Resalat Highway
City
Tehran
Postal code
Phone
+98 21 7788 3284
Fax
Email
sh.farsi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences (Arash hospital)
Full name of responsible person
Zohreh Farsi
Position
neonatologist
Other areas of specialty/work
Street address
Alley No169, St. Baghdarniya, Bagheri Highway, Resalat Highway
City
Tehran
Postal code
Phone
+98 21 7788 3284
Fax
Email
sh.farsi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences (Arash hospital)
Full name of responsible person
Zohreh Farsi
Position
neonatologist
Other areas of specialty/work
Street address
Alley No169, St. Baghdarniya, Bagheri Highway, Resalat Highway
City
Tehran
Postal code
Phone
+98 21 7788 3284
Fax
Email
sh.farsi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)