Comparison of the less invasive surfactant administration (LISA) with the usual method of surfactant injection (INSURE) in respiratory distress syndrome in neonates
Comparison of the less invasive surfactant administration with the usual method of surfactant injection in respiratory distress syndrome in neonates
Design
A clinical trial with a control group, with a parallel group, blinded on one side, randomization by creating blocks on 84 patients.
Settings and conduct
Premature neonates born with gestational age less than 34 weeks of gestation who have respiratory distress syndrome and are admitted in neonatal intensive care unit of Ayatollah Mousavi Hospital in Zanjan enter in one of control or intervention groups and then based on the prepared checklist, information about the variables are recorded and evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria : neonates with a gestational age less than or equal to 34 weeks who were not intubated at birth and are placed on non-invasive respiratory support and require surfactant injection due to moderate or severe respiratory distress.
Exclusion criteria :1- congenital anomalies
2- Congenital pulmonary structural disease
3- Congenital heart disease
4- neonates who underwent advanced resuscitation at birth
5- neonates who were intubated at birth due to severe respiratory distress
6- neonates with a gestational age of less than 26 weeks
Intervention groups
In the control group, neonates received Beraksurf at a dose of 4 cc per kilogram intratracheally with the usual method of surfactant injection, and in the intervention group, Beraksurf at a dose of 4 cc For each kilogram, they will receive surfactant injection intratracheally with less invasive surfactant administration .
Main outcome variables
The need for re-intubation; The incidence of pneumothorax; the incidence of pulmonary bleeding; The incidence of cerebral intraventricular hemorrhage; the duration of the need for non-invasive respiratory support; death rate; Duration of mechanical ventilation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049802N4
Registration date:2024-05-07, 1403/02/18
Registration timing:prospective
Last update:2024-05-07, 1403/02/18
Update count:0
Registration date
2024-05-07, 1403/02/18
Registrant information
Name
Asghar Marzban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1292
Email address
drmarzban@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the less invasive surfactant administration (LISA) with the usual method of surfactant injection (INSURE) in respiratory distress syndrome in neonates
Public title
Comparison of surfactant injection method in neonates with respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with a gestational age less than or equal to 34 weeks
Neonates who were not intubated at birth
Neonates who are on non-invasive respiratory support at birth
Moderate or severe respiratory distress
FIO2 requirement greater than 40%
need surfactant injection
Exclusion criteria:
Congenital abnormalities
Congenital structural pulmonary disease
Congenital heart disease
neonates who underwent advanced resuscitation at birth
neonates who were intubated due to severe respiratory distress at birth
neonates with a gestational age of less than 26 weeks
Age
To 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates eligible to enter the study will be allocated to each of the two groups by block randomization method and blinding will be observed. The block randomization method is used to allocate the samples to each of the groups. For this purpose, blocks of 6 will be used, and the site«sealedenvelope.com» will be used to synthesize the blocks. Due to the blinding done, the possibility of identifying the assigned group is prevented.
Blinding (investigator's opinion)
Single blinded
Blinding description
One-way blinding is considered for the participants who are neonates. Given that blinding is not applicable for the researcher, a consent form will be obtained from all parents, in which it is mentioned that surfactant injection to eligible neonates with One of the intervention or control methods will be done randomly, and the parents and the neonates will not know about the chosen method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
The need for intubation in the first 72 hours of birth
Timepoint
The first 72 hours of birth
Method of measurement
Record patient file information
Secondary outcomes
1
Description
Incidence of Pneumothorax
Timepoint
From patient admission to hospital discharge
Method of measurement
Clinical observation and chest x ray
2
Description
Duration requires Mechanical ventilation
Timepoint
From patient admission to hospital discharge
Method of measurement
Count the days required for a mechanical ventilation
3
Description
Incidence of pulmonary hemorrhage
Timepoint
From patient admission to hospital discharge
Method of measurement
Clinical observation and chest x ray
4
Description
Incidence of Intraventricular hemorrhage
Timepoint
At 7, 14 and 30 days if hospitalized
Method of measurement
Brain Sonography
5
Description
Need the next dose of Surfactant
Timepoint
The first three days of hospitalization
Method of measurement
Record patient file information
6
Description
Incidence of death
Timepoint
Incidence of death from admission to hospital discharge
Method of measurement
Physical examination
7
Description
Duration of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
Count the number of hospitalization days
8
Description
Duration of need for non-invasive ventilation
Timepoint
From patient admission to hospital discharge
Method of measurement
Number of days required for non-invasive ventilation
Intervention groups
1
Description
Intervention group: Hospitalized neonates receive Beraksurf vial at a dose of 4 cc per kilogram by intratracheal method. Beraksurf is a natural surfactant. Each vial of Beraksurf (Beractant) which was used in this study contains 4 cc suspension containing 100 mg of phospholipid obtained from cow's lung (Made by Artafarmed Company from Iran) and may be prescribed every 6-12 hours if needed during the first 72 hours of birth. Vials should be warmed to room temperature by hand holding for several minutes before use and should be gently inverted several times without shaking to create a uniform suspension.The suspensions are drawn using a sterile needle and syringe, then using the less invasive surfactant administration method (LISA) such that a 5F or 6F catheter is passed through the vocal cords under direct vision and using a laryngoscope without receiving sedation while that the neonate is under NCPAP, enters the trachea, then after the catheter passes through the vocal cords for 1 cm, the laryngoscope is removed, then Beraksurf is injected within a minute and the catheter is removed.
Category
Treatment - Devices
2
Description
Control group: Hospitalized neonates receive Beraksurf vial at a dose of 4 cc per kilogram by intratracheal method. Beraksurf is a natural surfactant. Each vial of Beraksurf (Beractant) which was used in this study contains 4 cc suspension containing 100 mg of phospholipid obtained from cow's lung (Made by Artafarmed Company from Iran) and may be prescribed every 6-12 hours if needed during the first 72 hours of birth. Vials should be warmed to room temperature by hand holding for several minutes before use and should be gently inverted several times without shaking to create a uniform suspension.The suspensions are drawn using a sterile needle and syringe ,Then with the method of intubation-surfactant injection-extubation (INSURE) in such a way that the neonate is intubated with a suitable size tracheal tube, then Beraksurf is injected, and during the injection, an ambobag (self-expanding balloon) is used with gentle pressure, Then, in case of stable vital signs and spontaneous breathing, the patient is extubated and placed under NCPAP.