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The Effect of Budesonide Inhaler on chronic lung disease prevention in neonates with RDS and gestational age of lower than 28 weeks

The Effect of Budesonide Inhaler on chronic lung disease prevention in neonates with RDS and gestational age of lower than 28 weeks

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015112810430N6
Enrollment
70
Registered
2016-01-03
Start date
2015-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Chronic Lung Disease. Bronchitis, not specified as acute or chronic

Interventions

Intervention 1: Intervention Group: Aerosolized Budezonide is administered at 12 hours from birth and is continued each 12 hours for at most one week. Intervention 2: Control Group: In this group, A
Treatment - Drugs
Treatment - Other
Intervention Group: Aerosolized Budezonide is administered at 12 hours from birth and is continued each 12 hours for at most one week
Control Group: In this group, Aerosolized Budesonide is not administered and the patients are just treated with nCPAP

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 7 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: * 23 to 28 weeks gestational age. * compatible clinical symptoms of RDS (Respiratory Disease Syndrome) as (tachypnea, intercostal retraction, nasal flaring, grunting, and the need for supplemental oxygen). * letter of consent. Exclusion criteria: * congenital malformation. * prinatal asphyxia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Chronic lung disease prevention. Timepoint: 4 weeks after birth. Method of measurement: The need for supplementary oxygen.

Secondary

MeasureTime frame
Reduction in need for surfactant. Timepoint: 72 hours after birth. Method of measurement: The need for supplementary oxygen more than 40%.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Sadeghnia

Isfahan University of Medical Sciences

asadeghnia@gmail.com+98 31 3335 1777

Outcome results

None listed

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