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Completed

NCT Number: NCT05517499

Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

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.

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Key information

Conditions

Efficacy, Self

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Randomized clinical trial

Other names: no dexamethasone

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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