Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants with high risk of bronchopulmonary dysplasia admitted to the NICU of Ayatollah Mousavi Hospital in Zanjan in 2021-22.
Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants with high risk of bronchopulmonary dysplasia
Design
A randomized, double blinded, clinical trial with a parallel group design of 60 infants. Randomisation was carried out by Rand function of Microsoft Excel software.
Settings and conduct
In this clinical trial study, 60 eligible neonates admitted to the neonatal intensive care unit of Ayatollah Mousavi Hospital in Zanjan are randomly assigned into two groups of 30 and Are evaluated one week after receiving dexamethasone or hydrocortisone and from the day 28.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Fetal age less than 33 weeks.
The risk of bronchopulmonary dysplasia more than 60% according to the NICHD definition.
Exclusion criteria:
Active systemic or pulmonary infection.
Existence of congenital anomalies and metabolic diseases requiring surgery.
Intervention groups
Infants of the dexamethasone group will recieve Dexamethasone injection from day 14 of birth (0.2 mg per kg body weight for the first 3 days and 0.1 mg per kg body weight for the next 4 days) and infants of the hydrocortisone group will recieve hydrocortisone injection from the 14th day of birth (1 mg per kg of body weight for 7 days).
Main outcome variables
Oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049802N3
Registration date:2022-01-25, 1400/11/05
Registration timing:registered_while_recruiting
Last update:2022-01-25, 1400/11/05
Update count:0
Registration date
2022-01-25, 1400/11/05
Registrant information
Name
Asghar Marzban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1292
Email address
drmarzban@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants with high risk of bronchopulmonary dysplasia admitted to the NICU of Ayatollah Mousavi Hospital in Zanjan in 2021-22.
Public title
Comparative study of the effect of dexamethasone and injectable hydrocortisone in reducing the need for oxygen in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fetal age less than 33 weeks
The risk of bronchopulmonary dysplasia more than 60% according to the NICHD definition
Parental consent
Having recieved antenatal corticosteroid
Exclusion criteria:
Active systemic or pulmonary infection
Existence of congenital anomalies and metabolic diseases requiring surgery
Age
To 231 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be enrolled randomly in to one of the groups
based on inclusion criteria. Randomisation sequence will
be processed by Microsoft Excel program via
(RANDBETWEEN) command and numbers 0 and 1 will be
allocated to each group to choose the group of the
subject.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be a double-blind study in which the doctor and the patient (patient's mother) will not know the type of drug received by the patient (dexamethasone or hydrocortisone).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
Oxygen saturation
Timepoint
day 28 of birth
Method of measurement
pulse oximeter
Secondary outcomes
1
Description
Mechanical ventilation time
Timepoint
day 28 of birth
Method of measurement
Direct observation
2
Description
CPAP time
Timepoint
day 28 of birth
Method of measurement
Direct observation
3
Description
NICU hospitalization time
Timepoint
day 28 of birth
Method of measurement
Direct observation
4
Description
Pulse/Respiration rate
Timepoint
day 28 of birth
Method of measurement
Cardiac monitoring device
Intervention groups
1
Description
Intervention group Dexamethasone: Infants of the dexamethasone group will recieve Dexamethasone injection from day 14 of birth (0.2 mg per kg body weight for the first 3 days and 0.1 mg per kg body weight for the next 4 days).
Category
Treatment - Drugs
2
Description
Intervention group Hydrocortisone: Infants of the hydrocortisone group will recieve hydrocortisone injection from the 14th day of birth (1 mg per kg of body weight for 7 days).