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Completed
NCT07763119
Efficacy of Nebulised Inhalational Steroids in Neonates With Meconium Aspiration Syndrome
Conditions: Meconium Aspiration Syndrome
Sex: All
Ages: 0 Days – 28 Days
Healthy volunteers: No
Phase: PHASE3
Enrollment: 60
Sponsor: Khyber Teaching Hospital
Location: Khyber Teaching Hospital Peshawar Peshawar Khyber Pakhtunkhwa
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07763119). StuddyBuddy aggregates publicly available trial information.