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Protocol summary
This study will be conducted on 30 preterm neonates with gestational age of 37 weeks or lower hospitalized in the NICU ward of Ghaem hospital due to respiratory distress syndrome who cannot be disconnected from ventilator any longer than 14 days. Their disease is verified by a specialist and they will be randomly assigned to two groups of control and treatment. Both groups receive the same treatment but the intervention groups, in addition to Intravenous dexamethasone, receives hydrocortisone. Patient are unaware of groupings.
This study will be conducted on 60 preterm neonates with a gestational age of ≤37 weeks who are admitted to the Neonatal Intensive Care Unit (NICU) of Ghaem Hospital due to respiratory distress syndrome (RDS) and have been unable to be weaned from mechanical ventilation for at least 14 days. The diagnosis will be confirmed by a neonatologist. Eligible participants will be randomly assigned to either the intervention group or the control group. Both groups will receive the same standard treatment(antibiotic and caffein); however, the intervention group will additionally receive hydrocortisone. The participants' parents or legal guardians will be blinded to the group allocation.
This study will be conducted on 3060 preterm neonates with a gestational age of ≤37 weeks or lower hospitalized inwho are admitted to the Neonatal Intensive Care Unit (NICU ward) of Ghaem hospitalHospital due to respiratory distress syndrome who cannot(RDS) and have been unable to be disconnectedweaned from ventilator any longer thanmechanical ventilation for at least 14 days. Their disease is verifiedThe diagnosis will be confirmed by a specialist and theyneonatologist. Eligible participants will be randomly assigned to two groups ofeither the intervention group or the control and treatmentgroup. Both groups will receive the same treatment butstandard treatment(antibiotic and caffein); however, the intervention groups, in addition to Intravenous dexamethasone, receivesgroup will additionally receive hydrocortisone. Patient are unaware of groupingsThe participants' parents or legal guardians will be blinded to the group allocation.
این مطالعه بر روی 30 نوزاد پره ترم کمتر و مساوی 37 هفته انجام خواهد شد که به دلیل سندروم دیسترس تنفسی در بخش NICU بیمارستان قائم (عج)بستری شده و برای مدت بیشتر و مساوی 14 روز قابلیت جدا شدن از ونتیلاتور را ندارند. بیماری انها توسط پزشک متخصص تائید شده , بصورت تصادفی در دو گروه کنترل و مداخله قرار خواهند گرفت. هردوگروه تحت درمانهای یکسان قرار دارند ولی گروه مداخله علاوه بر درمان با دگزامتازون وریدی، هیدروکورتیزون نیز دریافت می کند. بیماران از نحوه گروه بندی مطلع نیستند
این مطالعه بر روی60 نوزاد پره ترم کمتر و مساوی 37 هفته انجام خواهد شد که به دلیل سندروم دیسترس تنفسی در بخش NICU بیمارستان قائم (عج)بستری شده و برای مدت بیشتر و مساوی 14 روز قابلیت جدا شدن از ونتیلاتور را ندارند. بیماری انها توسط پزشک متخصص تائید شده , بصورت تصادفی در دو گروه کنترل و مداخله قرار خواهند گرفت. هردوگروه تحت درمانهای یکسان قرار دارند(آنتی بیوتیک و کافیین ) ولی گروه مداخله هیدروکورتیزون نیز دریافت می کند. بیماران از نحوه گروه بندی مطلع نیستند.
این مطالعه بر روی 30روی60 نوزاد پره ترم کمتر و مساوی 37 هفته انجام خواهد شد که به دلیل سندروم دیسترس تنفسی در بخش NICU بیمارستان قائم (عج)بستری شده و برای مدت بیشتر و مساوی 14 روز قابلیت جدا شدن از ونتیلاتور را ندارند. بیماری انها توسط پزشک متخصص تائید شده , بصورت تصادفی در دو گروه کنترل و مداخله قرار خواهند گرفت. هردوگروه تحت درمانهای یکسان قرار دارنددارند(آنتی بیوتیک و کافیین ) ولی گروه مداخله علاوه بر درمان با دگزامتازون وریدی، هیدروکورتیزون نیز دریافت می کند. بیماران از نحوه گروه بندی مطلع نیستند.
Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be used for 5 days where in the first 3 days, it is administered twice daily with the dose of 0.5 mg/kg and in the next 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate's blood pressure is controlled 3 times each 24 hours and the blood sugar is checked twice a day using glucometer.
Control group: In this group, the common method will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered.
Intervention group: In this group, hydrocortisone will be administered for 5 days as follows: 0.5 mg/kg twice daily for the first 3 days, followed by 0.5 mg/kg once daily for the subsequent 2 days. During the intervention, the neonates' blood pressure will be monitored three times every 24 hours, and blood glucose will be measured twice daily using a glucometer.
Control group: In this group, participants will receive the conventional treatment methods routinely used in the NICU(antibiotic and caffein).
Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose ofhydrocortisone will be administered for 5 days as follows: 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be usedtwice daily for 5 days where in the first 3 days, it is administered twice daily with the dose offollowed by 0.5 mg/kg and inonce daily for the nextsubsequent 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate'sneonates' blood pressure is controlled 3will be monitored three times eachevery 24 hours, and the blood sugar is checkedglucose will be measured twice a daydaily using a glucometer. Control group: In this group, the common methodparticipants will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation withreceive the dose of 0.5 mg/kg /day will be administeredconventional treatment methods routinely used in the NICU(antibiotic and caffein).
گروه مداخله: در این گروه، دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد. علاوه بر آن، مصرف هیدروکورتیزون به مدت 5روز که به صورت 3 روز اول درمان با دو مرتبه مصرف 5/0 mg/kg ودو روز بعد یک مرتبه مصرف 5/0 mg/kg خواهد بود. در طی مداخله فشار خون نوزاد 3بار در 24 ساعت و قند خون 2 بار در روز با گلوکومتر چک میشود. گروه کنترل: در این گروه از روش متداول استفاده خواهد شد. دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد.
گروه مداخله: در این گروه از هیدروکورتیزون به مدت 5 روز استفاده می شود که 5/0 میلی گرم بر کیلوگرم دو بار در 3 روز اول درمان و 5/0 میلی گرم بر کیلوگرم یک بار در دو روز آینده خواهد بود. در طول مداخله، فشار خون نوزاد 3 بار در 24 ساعت و قند خون 2 بار در روز با دستگاه گلوکومتر چک می شود. گروه کنترل: در این گروه از روش های رایج استفاده خواهد شد(انتی بیوتیک وکافیین).
گروه مداخله: در این گروه، دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد. علاوه بر آن، مصرف هیدروکورتیزون به مدت 5روز5 روز استفاده می شود که به صورت5/0 میلی گرم بر کیلوگرم دو بار در 3 روز اول درمان با دو مرتبه مصرفو 5/0 mg/kg ودومیلی گرم بر کیلوگرم یک بار در دو روز بعد یک مرتبه مصرف 5/0 mg/kgآینده خواهد بود. در طیطول مداخله، فشار خون نوزاد 3بار3 بار در 24 ساعت و قند خون 2 بار در روز با دستگاه گلوکومتر چک میشودمی شود. گروه کنترل: در این گروه از روش متداولهای رایج استفاده خواهد شدشد(انتی بیوتیک وکافیین). دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد.
General information
30
60
3060
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The registered information was updated to correct an error in the initially entered sample size and to revise and complete the descriptions of the study methodology and intervention in accordance with the approved study protocol.
The registered information was updated to correct an error in the initially entered sample size and to revise and complete the descriptions of the study methodology and intervention in accordance with the approved study protocol.
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اصلاح اطلاعات ثبتشده بهدلیل اشتباه در ثبت اولیه تعداد نمونه و همچنین اصلاح و تکمیل توضیحات مربوط به روش مطالعه و مداخله، بهمنظور انطباق با پروتکل مصوب.
اصلاح اطلاعات ثبتشده بهدلیل اشتباه در ثبت اولیه تعداد نمونه و همچنین اصلاح و تکمیل توضیحات مربوط به روش مطالعه و مداخله، بهمنظور انطباق با پروتکل مصوب.
Intervention groups
#1
Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be used for 5 days where in the first 3 days, it is administered twice daily with the dose of 0.5 mg/kg and in the next 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate's blood pressure is controlled 3 times each 24 hours and the blood sugar is checked twice a day using glucometer.
Intervention group: In this group, hydrocortisone will be administered for 5 days as follows: 0.5 mg/kg twice daily for the first 3 days, followed by 0.5 mg/kg once daily for the subsequent 2 days. During the intervention, the neonates' blood pressure will be monitored three times every 24 hours, and blood glucose will be measured twice daily using a glucometer.
Intervention group: In this group, Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose ofhydrocortisone will be administered for 5 days as follows: 0.5 mg/kg /day will be administered. In addition, hydrocortisone will be usedtwice daily for 5 days where in the first 3 days, it is administered twice daily with the dose offollowed by 0.5 mg/kg and inonce daily for the nextsubsequent 2 days, once daily with the dose of 0.5 mg/kg. During the intervention, the neonate'sneonates' blood pressure is controlled 3will be monitored three times eachevery 24 hours, and the blood sugar is checkedglucose will be measured twice a daydaily using a glucometer.
گروه مداخله: در این گروه، دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد. علاوه بر آن، مصرف هیدروکورتیزون به مدت 5روز که به صورت 3 روز اول درمان با دو مرتبه مصرف 5/0 mg/kg ودو روز بعد یک مرتبه مصرف 5/0 mg/kg خواهد بود. در طی مداخله فشار خون نوزاد 3بار در 24 ساعت و قند خون 2 بار در روز با گلوکومتر چک میشود.
گروه مداخله: در این گروه از هیدروکورتیزون به مدت 5روز که به صورت 3 روز اول درمان با دو مرتبه مصرف 5/0 mg/kg ودو روز بعد یک مرتبه مصرف 5/0 mg/kg استفاده خواهد شد. در طی مداخله فشار خون نوزاد 3بار در 24 ساعت و قند خون 2 بار در روز با گلوکومتر چک میشود.
گروه مداخله: در این گروه، دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد. علاوه بر آن، مصرف هیدروکورتیزون به مدت 5روز که به صورت 3 روز اول درمان با دو مرتبه مصرف 5/0 mg/kg ودو روز بعد یک مرتبه مصرف 5/0 mg/kg استفاده خواهد بودشد. در طی مداخله فشار خون نوزاد 3بار در 24 ساعت و قند خون 2 بار در روز با گلوکومتر چک میشود.
#2
Control group: In this group, the common method will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation with the dose of 0.5 mg/kg /day will be administered.
Control group: In this group, participants will receive the conventional treatment methods routinely used in the NICU.
Control group: In this group, the common methodparticipants will be used. Intravenous dexamethasone 24 hours before until 48 hours after extubation withreceive the dose of 0.5 mg/kg /day will be administeredconventional treatment methods routinely used in the NICU.
گروه کنترل: در این گروه از روش متداول استفاده خواهد شد. دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد.
گروه کنترل: در این گروه از روش های متداول استفاده خواهد شد.
گروه کنترل: در این گروه از روش های متداول استفاده خواهد شد. دگزامتازون وریدی به صورت 24 ساعت قبل وتا 48 ساعت بعد از اکستوباسیون با دوز 5/0 mg/kg /day استفاده خواهد شد.
Protocol summary
Study aim
Investigation of the effect of low-dose hydrocortisone on neonatal respiratory status under invasive and non-invasive mechanical ventilation
Design
Clinical trial with control and parallel groups, randomized and single blind
Settings and conduct
This study will be conducted on 60 preterm neonates with a gestational age of ≤37 weeks who are admitted to the Neonatal Intensive Care Unit (NICU) of Ghaem Hospital due to respiratory distress syndrome (RDS) and have been unable to be weaned from mechanical ventilation for at least 14 days. The diagnosis will be confirmed by a neonatologist. Eligible participants will be randomly assigned to either the intervention group or the control group. Both groups will receive the same standard treatment(antibiotic and caffein); however, the intervention group will additionally receive hydrocortisone. The participants' parents or legal guardians will be blinded to the group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: preterm neonates who have been under mechanical ventilation for at least 14 days, informed consent of the patient's legal guardian. Exclusion criteria: heart patients with failure, observable irregularities, neuromuscular diseases
Intervention groups
Intervention group: In this group, hydrocortisone will be administered for 5 days as follows: 0.5 mg/kg twice daily for the first 3 days, followed by 0.5 mg/kg once daily for the subsequent 2 days. During the intervention, the neonates' blood pressure will be monitored three times every 24 hours, and blood glucose will be measured twice daily using a glucometer.
Control group: In this group, participants will receive the conventional treatment methods routinely used in the NICU(antibiotic and caffein).
Main outcome variables
Status of need for mechanical ventilation; duration of connection to the ventilation device
General information
Reason for update
The registered information was updated to correct an error in the initially entered sample size and to revise and complete the descriptions of the study methodology and intervention in accordance with the approved study protocol.
Acronym
IRCT registration information
IRCT registration number:IRCT20200721048155N1
Registration date:2020-08-01, 1399/05/11
Registration timing:registered_while_recruiting
Last update:2026-09-05, 1405/06/14
Update count:1
Registration date
2020-08-01, 1399/05/11
Registrant information
Name
Raheleh Faramarzi Garmroudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2496
Email address
faramarzigr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-05, 1398/11/16
Expected recruitment end date
2021-08-07, 1400/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation
Public title
The effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonates who have been under mechanical ventilation for at least 14 days
Informed consent of the patient's legal guardian
Exclusion criteria:
Heart patients with failure
Observable irregularities
Neuromuscular diseases which influence respiratory effort
Age
From 7 days old to 30 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants as well as the person who assigns them to the two groups are not aware of the type of treatment and the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.139
Health conditions studied
1
Description of health condition studied
respiratory status under mechanical ventilation
ICD-10 code
P27.8
ICD-10 code description
Other chronic respiratory diseases originating in the perinatal period
Primary outcomes
1
Description
Status of need for mechanical ventilation based on level of oxygen needed
Timepoint
Before and during intervention and after disconnection from ventilation
Method of measurement
Patient monitoring device
2
Description
Duration of connection to the ventilation device
Timepoint
Before intervention
Method of measurement
Counting the number of days patient was connected to the ventilation device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, hydrocortisone will be administered for 5 days as follows: 0.5 mg/kg twice daily for the first 3 days, followed by 0.5 mg/kg once daily for the subsequent 2 days. During the intervention, the neonates' blood pressure will be monitored three times every 24 hours, and blood glucose will be measured twice daily using a glucometer.
Category
Treatment - Drugs
2
Description
Control group: In this group, participants will receive the conventional treatment methods routinely used in the NICU.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Raheleh Faramarzi
Street address
Ghaem hospital, Ahmad Abad blvd, Taghiabad sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
faramarzigr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
34591375
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Faramarzi Garmroudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmad Abad Av, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2496
Fax
Email
faramarzigr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Faramarzi Garmroudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmad Abad Av, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2496
Fax
Email
faramarzigr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Faramarzi Garmroudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmad Abad Av, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2496
Fax
Email
faramarzigr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.