Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Services Institute of Medical Sciences, Pakistan

Status: Completed

Conditions: Efficacy, Self

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05517499

IRB/2021/771/SIMS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Term and Post-Term babies who met the operational definition of MAS (inborn)
2. Presenting within 24 hours of life

Exclusion criteria

1. Preterm babies or babies with congenital malformations
2. Preterm babies or babies with dysmorphism
3. Preterm babies or babies with hypoxic-ischemic encephalopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group A (Dexamethasone Group),

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Group B (Control Group)

No Intervention group

Description:

Group B (Control group), received routine treatment.No dexamethasone