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 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.
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, 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.
Main outcome variables
Status of need for mechanical ventilation; duration of connection to the ventilation device
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200721048155N1
Registration date:2020-08-01, 1399/05/11
Registration timing:registered_while_recruiting
Last update:2020-08-01, 1399/05/11
Update count:0
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:
30
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, 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.
Category
Treatment - Drugs
2
Description
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.
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.