Comparison the effect of two method surfactant administration: Minimally invasive surfactant therapy)MIST) versus InSurE (Intubation, surfactant administration and extubation) in preterm neonates with respiratory distress syndrome: A randomized controlled trial
Evaluation of the effect of two method surfactant administration: Minimally invasive surfactant therapy(MIST) versus InSurE (Intubation, surfactant administration and extubation) in preterm neonates with respiratory distress syndrome: A randomized controlled trial
Design
The design of this research was as a parallel study. In terms of blinding, it is double blinded, which will be performed on 180 patients. Block randomization method is used for randomization of patients in the control group (InSurE ) or MIST
Settings and conduct
Premature infants with a gestational age of 26 to 34 weeks with respiratory distress syndrome and requiring the administration of surfactants that are otherwise healthy are randomly divided into two groups and will be compared in terms of severity of clinical symptoms based on respiratory distress grading. The neonatal intervention group first escaped under the nasal CPAP and then underwent direct laryngoscopy to receive surfactant and a feeding tube was inserted into the infant's trachea and then while the infant was breathing spontaneously it was administered. In the control group, the infant is first placed under the nasal CPAP, then intubated to administer the surfactant and receives the same amount of surfactant through the endotracheal tube, and after the endotracheal tube is stabilized, the nasal CPAP is established. Therapeutic outcomes, complications and mortality during hospitalization are measured in two groups and then compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: preterm neonates with respiratory distress syndrome; Exclusion criteria: Congenital anomaly, need for mechanical ventilation at birth, congenital infection, asphyxia, need for artificial ventilation, congenital heart disease
Intervention groups
MIST
Main outcome variables
duration of need for mechanical ventilation, duration of oxygen therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220401054389N1
Registration date:2022-05-24, 1401/03/03
Registration timing:registered_while_recruiting
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Maryam Behmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0001
Email address
behmadim4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two method surfactant administration: Minimally invasive surfactant therapy)MIST) versus InSurE (Intubation, surfactant administration and extubation) in preterm neonates with respiratory distress syndrome: A randomized controlled trial
Public title
ٍٍEffect of two method surfactant administration on preterm neonates with respiratory distress syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonates of 26 to 34 weeks with respiratory distress syndrome
Exclusion criteria:
Preterm neonates of 26 to 34 weeks with respiratory distress syndrome
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Block randomization random allocation will be used as a reliable randomization method that leads to a balanced allocation of individuals in treatment groups at the end of each block. For this purpose, a list of random blocks is prepared using Random Allocation Software. Then according to the order of the contents of the blocks, which includes the group name and patient number, each patient is assigned to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Upon the neonate's visit, the nurse accidentally opens one of the blocks, without knowing the allocations, presents one of the numbers to the neonatal fellowship, which is aware of the group type. It will be evolutionarily followed up in 4 times by a resident who does not know the allocation. Data registration in SPSS is done as groups A and B and the data analyzer does not know the intervention or control group. The follower and analyzer is not aware of the group.
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