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Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07763119
Enrollment
60
Registered
2026-08-13
Start date
2025-11-28
Completion date
2026-04-01
Last updated
2026-08-13

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

Conditions

Meconium Aspiration Syndrome

Keywords

Inhalational Steroids, Respiratory Distress, MAS

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. Primary and secondary outcome measures included: Treatment efficacy. Total hospital stay. Duration of NICU stay. Time to chest radiographic clearance. Time to achieve oxygen independence. Requirement for mechanical ventilation. Complications during hospitalization. In-hospital mortality. The study hypothesis was that adjunctive nebulised inhalational steroid therapy would shorten respiratory recovery and hospitalization while improving clinical outcomes compared with placebo in neonates with meconium aspiration syndrome. Data were analyzed using SPSS version 26.0, and statistical significance was defined as a two-sided p-value of ≤0.05.

Interventions

DRUGBudesonide

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

OTHERNormal Saline

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

Sponsors

Khyber Teaching Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group received nebulised inhalational steroid plus standard supportive care, while the control group received nebulised normal saline placebo plus standard supportive care. Outcomes were compared between the two groups throughout hospitalization.

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Recovery From Meconium Aspiration SyndromeFrom 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026