Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Efficacy, Self Clinical Trial

Official title:

Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517499
• Other study ID #: IRB/2021/771/SIMS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2022
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Efficacy, Self
• Meconium Aspiration Syndrome

Intervention

Drug:
• Dexamethasone
Randomized clinical trial

Locations

Country	Name	City	State
Pakistan	Services Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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