Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome

NCT07763119 | Completed Phase 3

• 1 other identifier: 387/DME/KMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Aspiration Syndrome

Keywords

Inhalational Steroids; Respiratory Distress; MAS

Outcome Measures

Primary Outcomes (1)

• Clinical Recovery From Meconium Aspiration Syndrome

  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.

  From randomization until hospital discharge (up to 28 days)

Study Arms (2)

Nebulised Inhalational Steroid

EXPERIMENTAL

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.

Drug: Budesonide

Normal Saline Placebo

PLACEBO COMPARATOR

Neonates received nebulised normal saline placebo in addition to the same standard supportive care provided to the intervention group.

Other: Normal Saline

Interventions

Budesonide DRUG

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

Nebulised Inhalational Steroid

Normal Saline OTHER

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

Normal Saline Placebo

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Major congenital anomalies.
• Congenital heart disease.
• Respiratory distress due to causes other than meconium aspiration syndrome.
• Previous corticosteroid therapy before enrollment.

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Meconium Aspiration Syndrome; Dyspnea

Interventions

Budesonide; Saline Solution

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee medical officer

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: November 28, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

PA (1)