Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

August 25, 2022 updated by: Services Institute of Medical Sciences, Pakistan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Services Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Dexamethasone
Randomized clinical trial
Other Names:
  • no dexamethasone
No Intervention: Group B (Control Group)
Group B (Control group), received routine treatment.No dexamethasone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Investigators

  • Study Chair: Uzair Qureshi, FCPS, Services Institute of Medical Sciences, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2021/771/SIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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