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"Effect of budesonide nebulizer on reducing BPD"

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230823059227N1
Enrollment
70
Registered
2023-09-13
Start date
2023-09-22
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary dysplasia. Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention 1: Intervention group: treatment with inhaler Budesonide through jet nebulizer (250 mcg every 12 hours) for 7 days. Intervention 2: Control group:prescribe 3 cc of 0.9% normal saline ne

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Days

Inclusion criteria

Inclusion criteria: Premature neonates between 24 and 32 weeks

Exclusion criteria

Exclusion criteria: Weight Less than 500 grams or more than 1500 grams Neonate with fatal congenital abnormalities or disorders and congenital heart and lung diseases Pneumothorax prior to randomization clinical evidence of early onset sepsis prior to randomization

Design outcomes

Primary

MeasureTime frame
Bronchopulmonary dysplasia. Timepoint: 36 weeks PMA or discharge to home, whichever occurred first. Method of measurement: According to the NICHD2001 ,The need for supplemental oxygen at 28 PMA.;Mortality. Timepoint: daily. Method of measurement: until discharge.

Secondary

MeasureTime frame
The duration of hospitalization. Timepoint: Discharge Time. Method of measurement: The number of days of hospitalization records.;Duration of need for oxygen. Timepoint: Daily. Method of measurement: Days count before O2 discontinue.;Duration of non-invasive ventilation. Timepoint: Day. Method of measurement: days of non-invasive ventilation.;Duration of mechanical ventilation. Timepoint: daily. Method of measurement: days of mechanical ventilation.;Intraventricular hemorrhage. Timepoint: daily. Method of measurement: based on cranial ultrasonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKobra Hosseini

Karaj University of Medical Sciences

Kobra.hosseini1990@gmail.com+98 26 3434 9590

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026