Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedAugust 26, 2022
August 1, 2022
6 months
May 20, 2022
August 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Group A (Dexamethasone Group),
EXPERIMENTALGroup 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 B (Control Group)
NO INTERVENTIONGroup B (Control group), received routine treatment.No dexamethasone
Interventions
Randomized clinical trial
Eligibility Criteria
You may qualify if:
- Term and Post-Term babies who met the operational definition of MAS (inborn)
- Presenting within 24 hours of life
You may not qualify if:
- Preterm babies or babies with congenital malformations
- Preterm babies or babies with dysmorphism
- Preterm babies or babies with hypoxic-ischemic encephalopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Services Hospital Lahore
Lahore, Punjab Province, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Uzair Qureshi, FCPS
Services Institute of Medical Sciences, Pakistan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
August 26, 2022
Study Start
January 1, 2021
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 26, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share