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Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

Primary Purpose

Efficacy, Self

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy, Self

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A (Dexamethasone Group),

Group B (Control Group)

Arm Description

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

Outcomes

Primary Outcome Measures

The number of days required for ventilation in participants
The purpose of study was to measure number of days required for ventilation in participants
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
The number of days required for hospitalization in participants
The purpose of study was to measure number of days required for hospitalization in participants

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
August 25, 2022
Sponsor
Services Institute of Medical Sciences, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05517499
Brief Title
Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
Official Title
Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Self

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Dexamethasone Group),
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (Control Group)
Arm Type
No Intervention
Arm Description
Group B (Control group), received routine treatment.No dexamethasone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
no dexamethasone
Intervention Description
Randomized clinical trial
Primary Outcome Measure Information:
Title
The number of days required for ventilation in participants
Description
The purpose of study was to measure number of days required for ventilation in participants
Time Frame
7 days
Title
The number of days required for oxygen therapy in participants
Description
The purpose of study was to measure number of days required for oxygen therapy in participants
Time Frame
7 days
Title
The number of days required for hospitalization in participants
Description
The purpose of study was to measure number of days required for hospitalization in participants
Time Frame
7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzair Qureshi, FCPS
Organizational Affiliation
Services Institute of Medical Sciences, Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome

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