A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome.
Comparison between effects administration of intratracheal surfactant and surfactant/budesonide concomitantly in preterm infants with respiratory distress syndrome in Ayatollah Mousavi Hospital in Zanjan.
Design
Clinical trial with control group, with parallel group,Not Blinded, Randomised trial with random sequencing on 134 patients.
Settings and conduct
All premature infants born with gestational age less than 37 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 included premature infants below 37 week's of gestation with moderate to severe Respiratory Distress Syndrome and: Weight less than 2500 grams; Need to mechanical ventilation; Need to inhale more than 30% oxygen for below 28 weeks of gestation and more than 40% in above 28 weeks of gestation.
Exclusion criteria included: Weight less than 700 grams; Severe congenital anomaly; Fatal cardiopulmonary disease; Other causes respiratory distress such as Congenital Diaphragmatic Hernia.
Intervention groups
In the control group, neonates receive intratracheal Surfactant at a dose of 2.5 cc/kg and in the intervention group, neonates were traeted with intratracheal Surfactant 2.5 cc/kg mixed by 1 cc/kg of Budesonide solution.
Main outcome variables
Incidence of death; Bronchopulmonary dysplasia; Duration of mechanical ventilation; Need the next doses surfactant; Length of hospital stay; oxygen index on the first and third days of treatment; Mean airway pressure on the first and third days of treatment; Incidence of pneumothorax; Pulmonary hemorrhage; Intracerebral hemorrhage; Mean systolic and diastolic blood pressure; Blood sugar.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049802N1
Registration date:2021-02-28, 1399/12/10
Registration timing:registered_while_recruiting
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
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
2021-01-04, 1399/10/15
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome.
Public title
A Comparative Study of Concomitant Intratracheal Administration of Surfactant with Budesonide with Surfactant alone in Premature Infants with Respiratory Distress Syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature Infant Less than 37 week's with Moderate or severe RDS
Weight less than 2500 grams
Requires Mechanical Ventilation
Requires FiO2 more than 30% at Gestational age under 28 week's and more than 40% at Gestational age more than 28 week's.
Exclusion criteria:
Weight Less than 700 grams
Severe Congenital Anomalies
Fatal Cardiopulmonary Disease
Other causes for Respiratory Distress Include Congenital Diaphragmatic Hernia
Age
To 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized by random sequencing on 134 patients. For this aim we used from random allocation method (by the method of variable blocks).
Blinding (investigator's opinion)
Not 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 Zanjan University of Medical Sciences
Incidence of death from admission to hospital discharge.
Method of measurement
Physical examination
2
Description
Incidence of Bronchopulmonary Dysplasia
Timepoint
Evaluation of Diagnostic criteria of Bronchopulmonary Dysplasia at 14 and 28 days after the start of the study.
Method of measurement
Evaluation of Diagnostic criteria
3
Description
Duration of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
Count the number of hospitalization days
4
Description
Duration requires Mechanical ventilation
Timepoint
From patient admission to hospital discharge
Method of measurement
Count the days required for a mechanical ventilation
5
Description
Incidence of Pneumothorax
Timepoint
From patient admission to hospital discharge
Method of measurement
Clinical observation and chest x ray.
6
Description
Incidence of pulmonary hemorrhage
Timepoint
From patient admission to hospital discharge
Method of measurement
Clinical observation and chest x ray
7
Description
Incidence of Intraventricular hemorrhage
Timepoint
At 7, 14 and 30 days if hospitalized.
Method of measurement
Brain Sonography
8
Description
Oxygen index on the first and third day of treatment
Timepoint
the first and third day of treatment
Method of measurement
Calculated using the formula. Mean airway pressure multiplied by fraction of Inspired oxygen divided by arterial oxygen pressure multiplied by 100.
9
Description
Mean airway pressure on the first and third day of treatment
Timepoint
the first and third day of treatment
Method of measurement
Using the number calculated by the Ventilator
10
Description
Need the next dose of Surfactant
Timepoint
The first three days of hospitalization
Method of measurement
Record patient file information.
11
Description
Mean systolic and diastolic blood pressure
Timepoint
The first and third day of treatment
Method of measurement
Using an oscillometric barometer attached to the monitor
12
Description
Blood Sugar level
Timepoint
The first and third day of treatment
Method of measurement
Using a Glucometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hospitalized infants receive 2.5 cc/kg Curosurf vial in combination with 1 cc/kg Pulmicort inhaler solution. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension with contains 240mg phospholipid fraction from Porcine lung. ( Made by Chiesie Pharma company of Italy). The recommended starting dose is 100-200 mg/kg ( 1.25- 2.5ml/kg), additional doses of 100mg/kg (1.25 ml/kg), each at about 6-12hourly intervals may also be administered if needed. Pulmicort inhaler solution used in this trial is 2cc suspension with 0.25 mg/ml concentration containing Budesonide. (Made by Swedish manufacture ASTRAZENECA which is imported by Cobel Daru company). The vials should be warmed to room temperature by holding it in the hand for a few minutes, before use, and gently turned upside down a few times, without shaking, in order to obtain a uniform suspension. The suspensions should be withdrawn from the vials using a sterile needle and syringe and mixed gently. A suitable tube should then be used to instill Curosurf with Budesonide into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient.
Category
Treatment - Drugs
2
Description
Control group:hospitalized infants receive Curosurf vial alone. Curosurf is a natural surfactant. each vial of Curosurf (Poractant alfa) used in this trial 3cc instillation suspension contains 240mg phospholipid fraction from Porcine lung. (Made by Chiesie Pharma company of Italy). The recommended starting dose is 1.25 - 2.5ml/kg and additional doses is 1.25 ml/kg, each at about 6-12hourly intervals may also be administered if needed. The vial should be warmed to room temperature by holding it in the hand for a few minutes before to use, The suspension should be withdrawn from the vial using a sterile needle and syringe. A suitable tube should then be used to instill Curosurf into the lung directly into the lower trachea by passing a catheter through the tube after intubation of patient.