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Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress

Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067736
Enrollment
84
Registered
2024-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: Budesonide inhalation: Subject will receive budesonide inhalation by nebulization every 12 hours for 3 days starting on day 4 of admission Control Intervention1: Sterile water: Subjects

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates (more than 34 weeks) up to 28 days of life with respiratory distress requiring an FiO2 more than 30 percent on day 4 of admission admitted in extra-mural NICU.

Exclusion criteria

Exclusion criteria: 1.Neonates who have non respiratory cause of respiratory distress (including congenital heart disease, Severe birth asphyxia, Polycythemia, Hypoglycemia etc.) 2.Neonates with Visible Gross Congenital Anomalies. 3.Neonates requiring exogenous surfactant.

Design outcomes

Primary

MeasureTime frame
Mean duration of oxygen requirementTimepoint: randomization to day of discharge—

Secondary

MeasureTime frame
Mean Downes scoreTimepoint: At enrollment and then every 12 hours till 72 hours of budesonide nebulization;Proportion of patients expiredTimepoint: randomization to day of expiry;Mean duration of NICU and hospital stayTimepoint: randomization to day of discharge—

Countries

India

Contacts

Public ContactDr Mohit Kumar Soni

University College of Medical Sciences and GTB hospital, Delhi

drprernabatra@yahoo.com9958672759

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026