Protocol summary
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Study aim
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Comparative study of the effect of intratracheal administration of Braksurf with curosurf on outcomes of neonates with respiratory distress syndrome admitted in intensive care unit of Kamali hospital in 2019-2020
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Design
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A clinical trial with parallel, single-blind, randomized, phase 3 on 100 patients will be randomized using randomly sized blocks of random size.
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Settings and conduct
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1- Identification of infants with respiratory distress syndrome
2- Selection of patients by available method and based on inclusion and exclusion criteria
3- Grouping patients into two groups receiving intratracheal crossover surfactant and Braxorph randomly.
4- Comparison of data obtained in two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Infants with respiratory distress disease
2- The result of pregnancy is equal and more than 25 weeks up to equal to 37 weeks
3- Admission to the study no later than 8 hours after birth
4. Requires fio2 more than 30%.
Exclusion criteria:
Severe asphyxia at birth 5 minutes less than 6 minutes
2- Diagnosis of congenital major abnormalities such as heart disease and severe life-threatening abnormalities
3 - Multiple anomalies
4 -Early malignant toxic sepsis
5- Rupture of embryonic membranes for more than 18 hours.
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Intervention groups
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Intervention group 1: (Braxorf) surfactant produced by Teximadaru company (with initial dose of 4 cc per kilogram of body weight, repeat each dose for 6 to 12 hours, if necessary, up to 4 doses intratracheally.
Intervention group 2: Kurosorf (surfactant produced by Chiesi Italy) with an initial dose of 2.5 cc per kilogram of body weight, repeat the dose every 12 hours, if necessary, up to 4 doses in the endotracheal.
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Main outcome variables
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Length of hospital stay, need and need for mechanical ventilation, BPD, death and drug side effects
General information
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Reason for update
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According to the investigator's opinion, study design needs to change.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170427033661N2
Registration date:
2020-12-16, 1399/09/26
Registration timing:
prospective
Last update:
2025-10-08, 1404/07/16
Update count:
1
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Registration date
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2020-12-16, 1399/09/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2021-07-21, 1400/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative study of the effect of intratracheal administration of Braksurf with curosurf on outcomes of neonates with respiratory distress syndrome admitted in intensive care unit
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Public title
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Comparative study of the effect of intratracheal administration of Braksurf with curosurf on outcomes of neonates with respiratory distress syndrome admitted in intensive care unit of Kamali hospital in 2019-2020
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Infants with respiratory distress
Pregnancy equal to and more than 25 weeks to equal to 37 weeks
Admission up to 8 hours after birth
Requires fio2 over 30%
Exclusion criteria:
Severe asphyxia at birth Apgar 5 minutes less than 6
Diagnosis of congenital major abnormalities such as heart disease and severe life-threatening abnormalities
Multiple anomalies
ٍEarly malignant toxic sepsis
Rupture of embryonic membranes for more than 18 hours
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Age
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From 1 day old to 28 days old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be performed using random blocks of non-matched size and Randomization .com site.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The infants participating in the study are blind to the medication they received.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-22, 1399/09/02
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Ethics committee reference number
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IR.ABZUMS.REC.1399.210
Health conditions studied
1
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Description of health condition studied
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Respiratory Distress Syndrome
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ICD-10 code
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P22.0
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ICD-10 code description
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Respiratory distress syndrome of newborn
Primary outcomes
1
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Description
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Length of hospital stay
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Timepoint
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End of the study
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Method of measurement
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Patient documentation
Secondary outcomes
1
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Description
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Duration requires mechanical ventilation
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Timepoint
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Patient discharge
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Method of measurement
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Hospital documentations
2
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Description
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Blood PH
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Timepoint
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The first 24 and 48 hours of life
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Method of measurement
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Based on arterial or venous blood samples
3
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Description
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HCO3
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Timepoint
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The first 24 and 48 hours of life
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Method of measurement
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Based on arterial or venous blood samples
4
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Description
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Pco2
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Timepoint
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The first 24 and 48 hours of life
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Method of measurement
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Based on arterial or venous blood samples
5
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Description
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sepsis
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Timepoint
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حین مطالعه
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Method of measurement
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General malaise with tachypnea / hypotension / unstable vital signs / positive blood or csf culture
6
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Description
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IVH
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Timepoint
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End of study
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Method of measurement
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Occurrence of intraventricular hemorrhage
7
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Description
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BPD
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Timepoint
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End of study
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Method of measurement
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Occurrence of oxygen dependence after 28 days
8
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Description
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Pneumothorax
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Timepoint
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End of study
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Method of measurement
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Occurrence of pneumothorax after injection by radiography
9
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Description
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Vital signs
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Timepoint
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Every 4 hours during the first 72 hours of a baby's life
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Method of measurement
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Measurement of heart rate, respiration rate, blood pressure and temperature
10
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Description
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Death
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Timepoint
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End of study
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Method of measurement
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Infant death
11
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Description
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Drug side effects
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Timepoint
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End of study
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Method of measurement
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Based on examination and history
Intervention groups
1
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Description
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Intervention group: (Braxorf) Surfactant manufactured by Teximadaru Company (with an initial dose of 4 cc per kilogram of body weight, repeat each dose for 6 to 12 hours, if necessary, up to 4 doses in the trachea.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Kurosorf (surfactant produced by the Italian company Chiesi) with an initial dose of 2.5 cc per kilogram of body weight, repeat the dose every 12 hours if needed, up to 4 doses in the trachea.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Alborz university of medical sience
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available