Efficacy, SelfNCT05517499
Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
A study testing Dexamethasone in people with Efficacy, Self, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Efficacy, Self
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and Post-Term babies who met the operational definition of MAS (inborn)
- Presenting within 24 hours of life
Who cannot join
- Preterm babies or babies with congenital malformations
- Preterm babies or babies with dysmorphism
- Preterm babies or babies with hypoxic-ischemic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Efficacy, Self
- Being tested
- Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called no dexamethasone
Randomized clinical trial
| Study group | Role | What they receive |
|---|---|---|
| Group A (Dexamethasone Group), | Experimental | 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 Receives: Drug: Dexamethasone |
| Group B (Control Group) | No intervention | Group B (Control group), received routine treatment.No dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days required for ventilation in participants
The purpose of study was to measure number of days required for ventilation in participants
Measured: 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
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy, SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Uzair Qureshi, FCPS, Study chair, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517499
- Sponsor's protocol ID
- IRB/2021/771/SIMS
- Status last verified
- Aug 2022
- First submitted
- 20 May 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome
- ClinicalTrials.gov ID
- NCT05517499
- Acronym / sponsor ID
- IRB/2021/771/SIMS
- Conditions
- Efficacy, Self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Dexamethasone Group), | Experimental | Drug: DexamethasoneGroup 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 intervention | –Group B (Control group), received routine treatment.No dexamethasone |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Term and Post-Term babies who met the operational definition of MAS (inborn)
- Presenting within 24 hours of life
Key exclusion criteria (3 listed)
- Preterm babies or babies with congenital malformations
- Preterm babies or babies with dysmorphism
- Preterm babies or babies with hypoxic-ischemic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: no dexamethasoneRandomized clinical trial | Drug | Group A (Dexamethasone Group), |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uzair Qureshi, FCPS study chair
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Efficacy, Self, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of days required for ventilation in participants (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.