Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Study Overview
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Brief Summary
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Objective: To determine efficacy of dexamethasone in treatment of meconium aspiration syndrome. Study design: Randomized control trial. Place and duration: Services hospital, Neonatal unit, Lahore. During time span of 1st January to 30th June 2021. Material and methods Total 100 neonates were randomly divided in two groups. Group A (n=50) was treated with dexamethasone (Cases) and Group B (n=50) served as control. Dexamethasone was given in dose of 0.2mg/kg, 12 hourly for 7 days after confirmation of diagnosis. Infants present in clinical trial were evaluated by ventilation duration (invasive and non-invasive), oxygen therapy and hospital stay.

Detailed Description
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Data was analyzed in statistical analysis SPSS version 23. Means and Standard deviation were calculated for duration of non-invasive and invasive ventilation, hospital stay and oxygen therapy. Independent sample T test was applied and value < 0.05 was taken as significant. Whereas frequency and percentages were taken for gender, gestation, mode of delivery and outcome of MAS and Chi-square test was applied, and p value < 0.05 was taken as significant.

Official Title
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Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Conditions
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Efficacy, Self

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term and Post-Term babies who met the operational definition of MAS (inborn) Presenting within 24 hours of life Exclusion Criteria: Preterm babies or babies with congenital malformations Preterm babies or babies with dysmorphism Preterm babies or babies with hypoxic-ischemic encephalopathy

Ages Eligible for Study
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Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Dexamethasone Group),<br>Group A (Case Group) was given dexamethasone i.e., 0.2 mg per kg per day every 12 hours for 7 days intravenously. All treatment strategies were same in both groups but steroid was given to group A | Drug: Dexamethasone<br>* Randomized clinical trial<br>* Other names: no dexamethasone;|
| No Intervention: Group B (Control Group)<br>Group B (Control group), received routine treatment.No dexamethasone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of days required for ventilation in participants | The purpose of study was to measure number of days required for ventilation in participants | 7 days | 
| The number of days required for oxygen therapy in participants | The purpose of study was to measure number of days required for oxygen therapy in participants | 7 days | 
| The number of days required for hospitalization in participants | The purpose of study was to measure number of days required for hospitalization in participants | 7 days |