A Phase 3 interventional study of Budesonide and Normal Saline in Meconium Aspiration Syndrome, sponsored by Khyber Teaching Hospital. Completed at 1 site in Pakistan. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Khyber Teaching Hospital · Phase 3, Interventional, and Treatment
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.
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.
25 studies on the registry are indexed under Meconium Aspiration Syndrome; 2 are open to participants now.
This study's enrollment of 60 is close to the median of 65 across 20 interventional studies indexed under Meconium Aspiration Syndrome.
Browse Meconium Aspiration Syndrome studies →Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Neonates received nebulised normal saline placebo in addition to the same standard supportive care provided to the intervention group.
Other: Normal Saline
Nebulised budesonide administered as adjunctive therapy together with standard supportive management for neonates with meconium aspiration syndrome.
Nebulised normal saline administered as placebo together with standard supportive management.
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.
Time frame: From randomization until hospital discharge (up to 28 days)
Ran from Nov 2025 to primary completion in Apr 2026, 4 months.
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Studies of the drug tested here: Budesonide
Meconium Aspiration Syndrome →
Khyber Teaching Hospital