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Completed
NCT07725575
Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary Dysplasia
Conditions: Bronchopulmonary Dysplasia (BPD)
Sex: All
Ages: N/A – 48 Hours
Healthy volunteers: No
Phase: PHASE4
Enrollment: 86
Sponsor: Indonesia University
Location: Cipto Mangunkusumo Hospital Jakarta DKI Jakarta
Summary
The goal of this clinical trial is to learn if budesonide works to prevent bronchopulmonary dysplasia in newborn less than 32 weeks gestational age or birth weight less than 1500 g with respiratory distress syndrome who needs surfactants. Does budesonide lower the incidence of bronchopulmonary dysplasia? What medical problems do participants have after given budesonide? Researchers will compare intratracheal budesonide and surfactant to intratracheal surfactant only to see if budesonide works to prevent bronchopumonary dysplasia.
Participants will:
Given intratracheal budesonide and surfactant and followed up until 36 weeks of post menstrual age to determine whether they have bronchopulmonary dysplasia or not
Eligibility Criteria
Inclusion Criteria:
* newborn
* birth weight less than 1500 g
* gestational age less than 32 weeks
* less than 48 hours of age
* diagnosed as respiratory distress syndrome and need surfactant
* get parental consent
Exclusion Criteria:
\- chromosom abnormality
* critical congenital heart disease
* congenital pulmonal disease
* Need surgery within 1 month
* mother with chorioamnionitis
* received postnatal corticosteroid before
Source: ClinicalTrials.gov (NCT07725575). StuddyBuddy aggregates publicly available trial information.