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COMPLETED
NCT07763119
PHASE3

Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome

Sponsor: Khyber Teaching Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of Nebulised Inhalational Steroids in Meconium Aspiration Syndrome: A Prospective Randomized Placebo-Controlled Clinical Trial

Key Details

Gender

All

Age Range

0 Days - 28 Days

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-28

Completion Date

2026-04-01

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

DRUG

Budesonide

Nebulised budesonide administered as adjunctive therapy together with standard supportive management for neonates with meconium aspiration syndrome.

OTHER

Normal Saline

Nebulised normal saline administered as placebo together with standard supportive management.

Locations (1)

Khyber Teaching Hospital Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan