Comparison prognosis the effect of two methods surfactant administration: Minimally invasive surfactant therapy(MIST) versus InSurE (Intubate, surfactant administration and extubate) in preterm neonates with respiratory distress syndrome at two year
Determining the effect of two methods of surfactant administration (MIST with InSurE method)) in infants with respiratory distress syndrome on the development of two years old
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 148 patients. Random Allocation Software is used for randomization.
Settings and conduct
In a double-blind clinical trial, we randomly assigned a preterm infant with a RDS and a need for surfactant born in the maternity ward and operating room of Ghaem Hospital in Mashhad to two intervention (MIST) and control groups (InSurE). We divide the follower and statistical analyst is not aware of the groups. we will follow these infants in terms of mortality and development until the age of two, and finally the two groups are compared based on the type of surfactant received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature infants with RDS with gestational age 26 to 34 weeks need surfactant
Conditions of absence: congenital anomaly or infection, history of developmental delay in the family
Intervention groups
In the neonatal under NCPAP intervention group, laryngoscopy was performed directly to receive surfactant and a feeding tube No. 5F was inserted and fixed in the infant's trachea, and then while the infant was breathing spontaneously, 100 mg/kg body weight of beractant was administered through the feed tube, during 1- 3 minute. Then the feed tube is removed and the NCPAP is continued.
In the control group, the infant underwent NCPAP to administer surfactant and received the same amount of surfactant through the endotracheal tube. After the neonatal condition was adjusted, the tube was removed and NCPAP was re-established.
Main outcome variables
The need for mechanical ventilation as a primary outcome and two-year prognosis as a secondary outcome are compared between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110807007244N8
Registration date:2022-06-11, 1401/03/21
Registration timing:registered_while_recruiting
Last update:2022-06-11, 1401/03/21
Update count:0
Registration date
2022-06-11, 1401/03/21
Registrant information
Name
Hassan Boskabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 515 3987
Email address
boskabadih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-07, 1401/03/17
Expected recruitment end date
2024-07-07, 1403/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison prognosis the effect of two methods surfactant administration: Minimally invasive surfactant therapy(MIST) versus InSurE (Intubate, surfactant administration and extubate) in preterm neonates with respiratory distress syndrome at two year
Public title
Comparison of the evolution of the effect of the two methods of prescribing the mature substance to the lungs of premature infants: Delicate endotracheal catheter during spontaneous respiration with intratracheal intubation in infants at two years of age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature infants with respiratory distress syndrome with a gestational age of 26 to 34 weeks require surfactant
Exclusion criteria:
Congenital anomaly
Requires mechanical ventilation in the delivery room
Congenital infection
Asphyxia
Congenital heart disease
History of developmental delay
Age
From 1 day old to 24 months old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The main researcher following the neonatal follow-up, the data collectors and the data analyzers are not aware of the groups.
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