Evaluation of the effect of use of budesonide nebulizer on reducing bronchopulmonary dysplasia in preterm infants less than 32 weeks a randomized of clinical trial
Clinical trial with control group with parallel groups, Double-blind, Randomized, Phase 3 on 180 patients.
Settings and conduct
kamali hospital
Participants/Inclusion and exclusion criteria
Preterm infants less than 32 weeks
Non-entry: less than 24 weeks of pregnancy
Birth weight less than 500 grams
fatal congenital anomalies and congenital heart and lung diseases
Pneumothorax
Fatal neonatal sepsis
Intervention groups
The first group will undergo treatment with inhaler Budesonide through jet nebulizer (250 mcg every 12 hours) for 7 days.
The second group was prescribed 2 cc of 0.9% normal saline nebulizer every 12 hours for 7 days.
Main outcome variables
Bronchopulmonary dysplasia
Mortality rate
Need for supplemental oxygen
Gestational age
Birth weight
Intraventricular hemorrhage
Duration of antibiotic treatment
Incidence of narcotizing enterocolitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059227N1
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:1
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Kobra Hosseini
Name of organization / entity
Alborz University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 26 3434 9590
Email address
kobra.hosseini1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-08-19, 1403/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of use of budesonide nebulizer on reducing bronchopulmonary dysplasia in preterm infants less than 32 weeks a randomized of clinical trial
Public title
"Effect of budesonide nebulizer on reducing BPD"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonates between 24 and 32 weeks
Exclusion criteria:
Weight Less than 500 grams
Neonate with fatal congenital abnormalities or disorders and congenital heart and lung diseases
Pneumothorax
Severe sepsis
Age
From 1 day old to 2 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized study, first, a randomization list will be prepared using the software under WEB at WWW.sealed envelope.com for randomization from block randomization with unequal block sizes of 2, 4, and 6 for concealment. Allocation will be done
Blinding (investigator's opinion)
Double blinded
Blinding description
Infants don't know the used drugs. Clinical manager administer prepared drug according patients code. Outcome is recorded by a nurse who is not aware administered drugs . Researcher is blind about patients groups and records data
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Science
Street address
Alborz University of Medical Science, Official settlement, North Taleghani boulevard, Taleghani Square, Karaj, Alborz Province
City
karaj
Province
Alborz
Postal code
3147734568
Approval date
2023-09-08, 1402/06/17
Ethics committee reference number
IR.ABZUMS.REC.1402.162
Health conditions studied
1
Description of health condition studied
Bronchopulmonary dysplasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
Broncopulmonary dysplasia
Timepoint
Daily
Method of measurement
The need for supplemental oxygen at 28 days of age
2
Description
Duration of hospitalization
Timepoint
Days of hospital stay
Method of measurement
Time between admission and discharge
3
Description
Duration of need for oxygen
Timepoint
Daily
Method of measurement
Days count before O2 discontinue
Secondary outcomes
1
Description
The duration of the treatment
Timepoint
Discharge Time
Method of measurement
The number of days of hospitalization records
Intervention groups
1
Description
Intervention group: treatment with inhaler Budesonide through jet nebulizer (250 mcg every 12 hours) for 7 days.
Category
Prevention
2
Description
Control group:prescribe 2 cc of 0.9% normal saline nebulizer every 12 hours for 7 days.