Clinical Trial

Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome

Completed Phase 3
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Summary
Meconium aspiration syndrome (MAS) is a major cause of respiratory distress in term and post-term neonates and is associated with significant neonatal morbidity. Inflammatory lung injury plays an important role in the pathophysiology of MAS, suggesting that corticosteroid therapy may improve respiratory recovery by reducing pulmonary inflammation and edema. This prospective, randomized, placebo-controlled clinical trial evaluated the efficacy of nebulised inhalational steroid therapy as an adjunct to standard supportive care in neonates with MAS admitted to the Neonatal Intensive Care Unit of Khyber Teaching Hospital, Peshawar. Sixty eligible neonates were randomly assigned in a 1:1 ratio to receive either nebulised inhalational steroid or nebulised normal saline placebo in addition to standard treatment. The primary objective was to determine whether inhalational steroid therapy improves clinical recovery. Outcomes included treatment efficacy, duration of hospital stay, NICU stay, time to chest radiographic clearance, oxygen independence, requirement for mechanical ventilation, complications during admission, and in-hospital mortality.
Trial Details
NCT Number NCT07763119
Lead Sponsor Khyber Teaching Hospital
Conditions Meconium Aspiration Syndrome
Enrollment 60 participants
Start Date 2025-11-28
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13