Efficacy of Nebulised Inhalational Steroids in Meconium Aspiration Syndrome: A Prospective Randomized Placebo-Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Khyber Teaching Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical Recovery From Meconium Aspiration Syndrome
Study Overview
Brief 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.
Detailed Description
Meconium aspiration syndrome (MAS) is an important cause of neonatal respiratory distress and remains associated with considerable morbidity despite advances in neonatal intensive care. Aspiration of meconium results in airway obstruction, surfactant inactivation, chemical pneumonitis, pulmonary edema, and activation of inflammatory pathways, leading to impaired gas exchange and respiratory failure. Although treatment is primarily supportive, persistent pulmonary inflammation may prolong oxygen dependence and hospitalization.
Corticosteroids possess potent anti-inflammatory properties and may reduce pulmonary inflammation, capillary permeability, and pulmonary edema. Nebulised administration allows direct drug delivery to the lungs while minimizing systemic exposure. Previous clinical studies have suggested potential benefits of corticosteroid therapy in MAS, although available evidence remains limited because of small sample sizes and differences in corticosteroid preparations, doses, and treatment protocols.
This study was designed as a prospective, randomized, placebo-controlled clinical trial conducted in the Department of Pediatric Medicine and Neonatal Intensive Care Unit, Khyber Teaching Hospital, Peshawar. After obtaining written informed consent from parents or legal guardians, eligible neonates diagnosed with meconium aspiration syndrome were randomly allocated in a 1:1 ratio to receive either nebulised inhalational steroid plus standard supportive care or nebulised normal saline placebo plus standard supportive care.
Supportive treatment included oxygen therapy, thermal regulation, fluid and nutritional management, antibiotic therapy when clinically indicated, and non-invasive or invasive respiratory support according to standard NICU practice.
The primary objective was to determine the efficacy of nebulised inhalational steroid therapy in improving clinical recovery in neonates with MAS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Neonates diagnosed with meconium aspiration syndrome.
- •Term or post-term neonates.
- •Admission to the Neonatal Intensive Care Unit (NICU) requiring treatment for meconium aspiration syndrome.
- •Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria
- •Major congenital anomalies.
- •Congenital heart disease.
- •Respiratory distress due to causes other than meconium aspiration syndrome.
- •Previous corticosteroid therapy before enrollment.
- •Neonates meeting any other exclusion criteria specified in the approved study protocol.
Arms & Interventions
Nebulised Inhalational Steroid
Neonates received nebulised inhalational steroid in addition to standard supportive care, including oxygen therapy, thermal regulation, nutritional support, antibiotics when clinically indicated, and respiratory support according to NICU protocols.
Intervention: Budesonide (Drug)
Normal Saline Placebo
Neonates received nebulised normal saline placebo in addition to the same standard supportive care provided to the intervention group.
Intervention: Normal Saline (Other)
Outcomes
Primary Outcomes
Clinical Recovery From Meconium Aspiration Syndrome
Time Frame: From randomization until hospital discharge (up to 28 days)
Clinical recovery was assessed based on resolution of respiratory distress and achievement of oxygen independence without the need for mechanical ventilation during hospitalization. The outcome was reported as the number and percentage of neonates who achieved clinical recovery in each treatment group.
Secondary Outcomes
No secondary outcomes reported
Investigators
Shahab Ud Din
Trainee medical officer
Khyber Teaching Hospital