PneumoniaNCT07438834
Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
A study testing Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) in people with Pneumonia and Respiration Disorders, run by University of Health Sciences Lahore.
Trial summary
Sedation is essential for mechanically ventilated pediatric patients to ensure comfort, ventilator synchrony, and prevention of self-extubation. However, excessive sedation may prolong mechanical ventilation and ICU stay, while inadequate sedation may cause agitation and physiological distress. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Pneumonia, Respiration Disorders
- What is being tested?
- Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with pneumonia
- Requiring mechanical ventilation for at least 48 hours
- Requiring sedation with intravenous Midazolam
- Written informed consent obtained from parent or legal guardian
Who cannot join
- Pre-existing neurological impairment (e.g., traumatic brain injury, stroke, cerebral palsy) that may interfere with comfort assessment
- Presence of central nervous system symptoms affecting sedation evaluation
- Contraindication to Midazolam (e.g., hypersensitivity, severe hypotension, significant hepatic dysfunction)
- Receiving multiple sedative agents in addition to Midazolam
- Refusal of parental or guardian consent
About this study
Official title: Comparison of Comfort Scores Between Continuous Midazolam Infusion and Daily Sedation Interruption in Mechanically Ventilated Pediatric Patients With Pneumonia: A Randomized Controlled Trial
Sedation is essential for mechanically ventilated pediatric patients to ensure comfort, ventilator synchrony, and prevention of self-extubation. However, excessive sedation may prolong mechanical ventilation and ICU stay, while inadequate sedation may cause agitation and physiological distress. Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) are two commonly used strategies. Limited data exist comparing their impact on comfort levels in pediatric patients.
This randomized controlled trial aims to compare comfort scores between continuous Midazolam infusion and daily sedation interruption in mechanically ventilated children aged 5-10 years diagnosed with pneumonia. Comfort will be assessed using the COMFORT-B Scale and Richmond Agitation-Sedation Scale (RASS) every 6 hours for 72 hours.
The study intends to determine which strategy better maintains optimal sedation and comfort in pediatric intensive care settings.
- Conditions
- Pneumonia, Respiration Disorders
- Being tested
- Continuous Sedation Infusion (CSI), Daily Sedation Interruption (DSI)
- Medical subject headings
- Pneumonia, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Sedation Infusion (CSI)Other
Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.
Daily Sedation Interruption (DSI)Other
Participants receive Midazolam infusion with daily interruption for 1-2 hours to assess neurological function and comfort level. Sedation is restarted if needed and titrated according to scoring scales.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Sedation Infusion (CSI) | Experimental | Not described Receives: Other: Continuous Sedation Infusion (CSI) |
| Daily Sedation Interruption (DSI) | Experimental | Not described Receives: Other: Daily Sedation Interruption (DSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean COMFORT-B Score
Measurement of patient comfort using the COMFORT-B Scale. Scores range from 6 to 30, with 11-22 indicating optimal sedation. Mean scores will be compared between the two intervention groups.
Measured: Every 6 hours during the first 72 hours of mechanical ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shamshad Shinwari, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438834
- Sponsor's protocol ID
- Exp135
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Comfort Scores Between Continuous Midazolam Infusion and Daily Sedation Interruption in Mechanically Ventilated Pediatric Patients With Pneumonia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07438834
- Acronym / sponsor ID
- Exp135
- Conditions
- Pneumonia, Respiration Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Sedation is essential for mechanically ventilated pediatric patients to ensure comfort, ventilator synchrony, and prevention of self-extubation. However, excessive sedation may prolong mechanical ventilation and ICU stay, while inadequate sedation may cause agitation and physiological distress. Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) are two commonly used strategies. Limited data exist comparing their impact on comfort levels in pediatric patients.
This randomized controlled trial aims to compare comfort scores between continuous Midazolam infusion and daily sedation interruption in mechanically ventilated children aged 5-10 years diagnosed with pneumonia. Comfort will be assessed using the COMFORT-B Scale and Richmond Agitation-Sedation Scale (RASS) every 6 hours for 72 hours.
The study intends to determine which strategy better maintains optimal sedation and comfort in pediatric intensive care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Sedation Infusion (CSI) | Experimental | Other: Continuous Sedation Infusion (CSI) |
| Daily Sedation Interruption (DSI) | Experimental | Other: Daily Sedation Interruption (DSI) |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with pneumonia
- Requiring mechanical ventilation for at least 48 hours
- Requiring sedation with intravenous Midazolam
- Written informed consent obtained from parent or legal guardian
Key exclusion criteria (5 listed)
- Pre-existing neurological impairment (e.g., traumatic brain injury, stroke, cerebral palsy) that may interfere with comfort assessment
- Presence of central nervous system symptoms affecting sedation evaluation
- Contraindication to Midazolam (e.g., hypersensitivity, severe hypotension, significant hepatic dysfunction)
- Receiving multiple sedative agents in addition to Midazolam
- Refusal of parental or guardian consent
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 |
|---|---|---|
| Continuous Sedation Infusion (CSI)Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol. | Other | Continuous Sedation Infusion (CSI) |
| Daily Sedation Interruption (DSI)Participants receive Midazolam infusion with daily interruption for 1-2 hours to assess neurological function and comfort level. Sedation is restarted if needed and titrated according to scoring scales. | Other | Daily Sedation Interruption (DSI) |
Primary outcome
Mean COMFORT-B Score
Time frame: Every 6 hours during the first 72 hours of mechanical ventilation.
Measurement of patient comfort using the COMFORT-B Scale. Scores range from 6 to 30, with 11-22 indicating optimal sedation. Mean scores will be compared between the two intervention groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) in people with Pneumonia and Respiration Disorders, run by University of Health Sciences Lahore.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Mean COMFORT-B Score (time frame: Every 6 hours during the first 72 hours of mechanical ventilation.). 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 27 Feb 2026.