Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

NCT ID: NCT05517499

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-30

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.

Conditions

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Efficacy, Self

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (Dexamethasone Group),

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Randomized clinical trial

Group B (Control Group)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone

Randomized clinical trial

Intervention Type DRUG

Other Intervention Names

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no dexamethasone

Eligibility Criteria

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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
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uzair Qureshi, FCPS

Role: STUDY_CHAIR

Services Institute of Medical Sciences, Lahore

Locations

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Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB/2021/771/SIMS

Identifier Type: -

Identifier Source: org_study_id

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