Protocol summary
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Study aim
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Investigation of the effect of low-dose hydrocortisone on neonatal respiratory status under invasive and non-invasive mechanical ventilation
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Design
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Clinical trial with control and parallel groups, randomized and single blind
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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Status of need for mechanical ventilation; duration of connection to the ventilation device
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-08-01, 1399/05/11
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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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2020-02-05, 1398/11/16
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Expected recruitment end date
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2021-08-07, 1400/05/16
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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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Investigation of the effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation
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Public title
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The effect of low-dose hydrocortisone on neonatal respiratory status under mechanical ventilation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 7 days old to 30 days old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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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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2020-02-04, 1398/11/15
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.139
Health conditions studied
1
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Description of health condition studied
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respiratory status under mechanical ventilation
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ICD-10 code
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P27.8
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ICD-10 code description
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Other chronic respiratory diseases originating in the perinatal period
Primary outcomes
1
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Description
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Status of need for mechanical ventilation based on level of oxygen needed
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Timepoint
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Before and during intervention and after disconnection from ventilation
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Method of measurement
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Patient monitoring device
2
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Description
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Duration of connection to the ventilation device
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Timepoint
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Before intervention
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Method of measurement
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Counting the number of days patient was connected to the ventilation device
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: In this group, participants will receive the conventional treatment methods routinely used in the NICU.
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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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Mashhad University of Medical Sciences
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data can be shared after patients are made unidentifiable.
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When the data will become available and for how long
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Data can be accessible 6 months after results are published.
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To whom data/document is available
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Data will be available for researchers in universities and other scientific institutes.
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Under which criteria data/document could be used
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Carrying out analysis on data is permitted.
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From where data/document is obtainable
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Data can be accessible through an email to the corresponding author.
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What processes are involved for a request to access data/document
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After sending a request email to the corresponding author, data will be sent in 1 month.
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Comments
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