Meconium Aspiration SyndromePhase 3NCT07763119
Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome
A Phase 3 study testing Budesonide and Normal Saline in people with Meconium Aspiration Syndrome, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Budesonide and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2025to 1 Apr 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Teaching Hospital Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Efficacy of Nebulised Inhalational Steroids in Meconium Aspiration Syndrome: A Prospective Randomized Placebo-Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Budesonide, Normal Saline
- Keywords
- Inhalational Steroids, Respiratory Distress, MAS
- Medical subject headings
- Meconium Aspiration Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Nebulised budesonide administered as adjunctive therapy together with standard supportive management for neonates with meconium aspiration syndrome.
Normal SalineOther
Nebulised normal saline administered as placebo together with standard supportive management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until hospital discharge (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start28 Nov 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Aspiration SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahab Ud Din, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763119
- Sponsor's protocol ID
- 387/DME/KMC
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No