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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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History
# Registration date Revision Id
2 2025-09-16, 1404/06/25 358375
1 2020-12-16, 1399/09/26 163271
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  • Protocol summary

    A clinical trial with parallel, single-blind, randomized, phase 3 on 150 patients will be randomized using randomly sized blocks of random size.
    A clinical trial with parallel, single-blind, randomized, phase 3 on 100 patients will be randomized using randomly sized blocks of random size.
    کارآزمایی بالینی با گروه های موازی ، یک سویه کور ، تصادفی شده، فاز 3 بر روی 150 بیمار که تصادفی سازی با استفاده از بلوکهای تصادفی با سایز غیر همسان انجام خواهد شد.
    کارآزمایی بالینی با گروه های موازی ، یک سویه کور ، تصادفی شده، فاز 3 بر روی 100 بیمار که تصادفی سازی با استفاده از بلوکهای تصادفی با سایز غیر همسان انجام خواهد شد.
    Inclusion criteria: 1- Infants with respiratory distress disease 2- The result of pregnancy is equal and more than 25 weeks up to equal to 35 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.
    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.
    معیار های ورود: 1- نوزادان مبتلا به بیماری زجر تنفسی 2- حاصل بارداری مساوی و بیشتر از 25 هفته تا مساوی 35 هفته 3- ورود به مطالعه حداکثرتا 8 ساعت بعد از تولد 4-نیاز به fio2 بیش از 30 درصد. معیار های خروج: 1- آسفیکسی شدید هنگام تولد اپگار دقیقه 5 کمتر از6 2- تشخیص ناهنجاری ماژور مادرزادی مثل بیماری قلبی و ناهنجاری شدید تهدید کننده حیات 3 - مولتیپل آنومالی 4 - سپسیس سمی زودرس بدخیم 5- پارگی پرده های جنینی بیش از 18 ساعت.
    معیار های ورود: 1- نوزادان مبتلا به بیماری زجر تنفسی 2- حاصل بارداری مساوی و بیشتر از 25 هفته تا مساوی 37 هفته 3- ورود به مطالعه حداکثرتا 8 ساعت بعد از تولد 4-نیاز به fio2 بیش از 30 درصد. معیار های خروج: 1- آسفیکسی شدید هنگام تولد اپگار دقیقه 5 کمتر از6 2- تشخیص ناهنجاری ماژور مادرزادی مثل بیماری قلبی و ناهنجاری شدید تهدید کننده حیات 3 - مولتیپل آنومالی 4 - سپسیس سمی زودرس بدخیم 5- پارگی پرده های جنینی بیش از 18 ساعت.
    FIO2 level, need and need for mechanical ventilation, length of hospital stay, BPD, death and drug side effects
    Length of hospital stay, need and need for mechanical ventilation, BPD, death and drug side effects
    میزان FIO2، نیاز و طول مدت تهویه مکانیکی، مدت زمان بستری در بیمارستان،BPD ، مرگ وعوارض دارویی
    مدت زمان بستری در بیمارستان، نیاز و طول مدت تهویه مکانیکی،BPD ، مرگ وعوارض دارویی

  • General information

    150
    100
    empty
    According to the investigator's opinion, study design needs to change.
    empty
    با توجه به نظر محقق نیاز به اعمال تغییرات در طراحی مطالعه هست
    Infants with respiratory distress
    Pregnancy equal to and more than 25 weeks to equal to 35 weeks
    Admission up to 8 hours after birth
    Requires fio2 over 30%
    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%
    نوزادان مبتلا به بیماری زجر تنفسی
    حاصل بارداری مساوی و بیشتر از 25 هفته تا مساوی 35 هفته
    ورود به مطالعه حداکثرتا 8 ساعت بعد از تولد
    نیاز به fio2 بیش از 30 درصد
    نوزادان مبتلا به بیماری زجر تنفسی
    حاصل بارداری مساوی و بیشتر از 25 هفته تا مساوی 37 هفته
    ورود به مطالعه حداکثرتا 8 ساعت بعد از تولد
    نیاز به fio2 بیش از 30 درصد

  • Primary outcomes

    #1
    FIO2
    Length of hospital stay
    FIO2
    طول مدت بستری
    Every 4 hours during the first 72 hours of a baby's life
    End of the study
    هر 4 ساعت در طی 72 ساعت اول تولد نوزاد
    انتهای مطالعه
    Ventilator system
    Patient documentation
    سیستم ونتیلاتور
    پرونده بیمارستان

  • Secondary outcomes

    #1
    مرور پرونده بیمارستانی
    Hospital documentations
    #2
    HCO3
    بی‌کربنات
    #3
    Pco2
    فشار گاز CO2 در خون
    #4
    سپسیس
    سپسیس (عفونت)
    #5
    Hospitalization
    IVH
    بستری
    خونریزی داخل بطنی
    Duration Requires NICU
    Occurrence of intraventricular hemorrhage
    طول مدت نیاز به NICU
    وقوع خونریزی داخل بطنی
    #6
    IVH
    BPD
    IVH
    دیسپلازی برونکوپولمونری (bronchopulmonary dysplasia; BPD) یک بیماری در نوزادان نارس است که نیاز به حمایت طولانی‌مدت با تنفس و اکسیژن مکمل دارد
    Occurrence of intraventricular hemorrhage
    Occurrence of oxygen dependence after 28 days
    وقوع خونریزی داخل بطنی
    وقوع میزان وابستگی به اکسیژن بعد 28 روزگی
    #7
    BPD
    Pneumothorax
    BPD
    پنوموتوراکس ( Pneumothorax ) یا هواجَنبی به معنی وجود هوا در حفره جنب است که مانع باز شدن کامل ریه می‌شود.
    Occurrence of oxygen dependence after 28 days
    Occurrence of pneumothorax after injection by radiography
    وقوع میزان وابستگی به اکسیژن بعد 28 روزگی
    وقوع پنوموتوراکس بعد از تزریق از طریق رادیوگرافی
    #8
    Pneumothorax
    Vital signs
    پنوموتوراکس
    علایم حیاتی
    End of study
    Every 4 hours during the first 72 hours of a baby's life
    انتهای مطالعه
    هر 4 ساعت در طی 72 ساعت اول تولد نوزاد
    Occurrence of pneumothorax after injection by radiography
    Measurement of heart rate, respiration rate, blood pressure and temperature
    وقوع پنوموتوراکس بعد از تزریق از طریق رادیوگرافی
    اندازه گیری ضربان قلب، تعداد تنفس، فشار خون و دما
    #9
    Vital signs
    Death
    علایم حیاتی
    مرگ
    Every 4 hours during the first 72 hours of a baby's life
    End of study
    هر 4 ساعت در طی 72 ساعت اول تولد نوزاد
    انتهای مطالعه
    Measurement of heart rate, respiration rate, blood pressure and temperature
    Infant death
    اندازه گیری ضربان قلب، تعداد تنفس، فشار خون و دما
    مرگ نوزاد
    #10
    Death
    Drug side effects
    مرگ
    عوارض دارویی
    Infant death
    Based on examination and history
    مرگ نوزاد
    بر اساس معاینه و شرح حال
    #11
    Drug side effects
    empty
    عوارض دارویی
    empty
    End of study
    empty
    انتهای مطالعه
    empty
    Based on examination and history
    empty
    بر اساس معاینه و شرح حال
    empty

Protocol summary

Study aim
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
Design
A clinical trial with parallel, single-blind, randomized, phase 3 on 100 patients will be randomized using randomly sized blocks of random size.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Length of hospital stay, need and need for mechanical ventilation, BPD, death and drug side effects

General information

Reason for update
According to the investigator's opinion, study design needs to change.
Acronym
IRCT registration information
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
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Alireza Jashnimotlagh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
dr.jashnimotlagh@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using random blocks of non-matched size and Randomization .com site.
Blinding (investigator's opinion)
Single blinded
Blinding description
The infants participating in the study are blind to the medication they received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz University of Medical Science
Street address
Alborz University of Medical Science, Office Park, Taleghani Square, Azimieh
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.ABZUMS.REC.1399.210

Health conditions studied

1

Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Length of hospital stay
Timepoint
End of the study
Method of measurement
Patient documentation

Secondary outcomes

1

Description
Duration requires mechanical ventilation
Timepoint
Patient discharge
Method of measurement
Hospital documentations

2

Description
Blood PH
Timepoint
The first 24 and 48 hours of life
Method of measurement
Based on arterial or venous blood samples

3

Description
HCO3
Timepoint
The first 24 and 48 hours of life
Method of measurement
Based on arterial or venous blood samples

4

Description
Pco2
Timepoint
The first 24 and 48 hours of life
Method of measurement
Based on arterial or venous blood samples

5

Description
sepsis
Timepoint
حین مطالعه
Method of measurement
General malaise with tachypnea / hypotension / unstable vital signs / positive blood or csf culture

6

Description
IVH
Timepoint
End of study
Method of measurement
Occurrence of intraventricular hemorrhage

7

Description
BPD
Timepoint
End of study
Method of measurement
Occurrence of oxygen dependence after 28 days

8

Description
Pneumothorax
Timepoint
End of study
Method of measurement
Occurrence of pneumothorax after injection by radiography

9

Description
Vital signs
Timepoint
Every 4 hours during the first 72 hours of a baby's life
Method of measurement
Measurement of heart rate, respiration rate, blood pressure and temperature

10

Description
Death
Timepoint
End of study
Method of measurement
Infant death

11

Description
Drug side effects
Timepoint
End of study
Method of measurement
Based on examination and history

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان کمالی
Full name of responsible person
Dr Alireza jashni motlagh
Street address
Shohada Square, Kamali St., Kamali Educational and Medical Center
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
Kamali@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz university of medical sience
Full name of responsible person
Alireza Jashni Motlagh
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz university of medical sience
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Alireza Jashni Motlagh
Position
Neonatal subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shohada Square, Kamali St, Kamali Educational and Medical Center
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
dr.jashnimotlagh@abzums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Alireza Jashni Motlagh
Position
Neonatal subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shohada Square, Kamali St, Kamali Educational and Medical Center
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
dr.jashnimotlagh@abzums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr Alireza Jashni Motlagh
Position
Neonatal subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shohada Square, Kamali St, Kamali Educational and Medical Center
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
dr.jashnimotlagh@abzums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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