Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:42 PM
Study NCT ID:
NCT07438834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean COMFORT-B Score', 'timeFrame': 'Every 6 hours during the first 72 hours of mechanical ventilation.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia', 'Respiration Disorders']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe study intends to determine which strategy better maintains optimal sedation and comfort in pediatric intensive care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed with pneumonia\n\nRequiring mechanical ventilation for at least 48 hours\n\nRequiring sedation with intravenous Midazolam\n\nWritten informed consent obtained from parent or legal guardian\n\nExclusion Criteria:\n\nPre-existing neurological impairment (e.g., traumatic brain injury, stroke, cerebral palsy) that may interfere with comfort assessment\n\nPresence of central nervous system symptoms affecting sedation evaluation\n\nContraindication to Midazolam (e.g., hypersensitivity, severe hypotension, significant hepatic dysfunction)\n\nReceiving multiple sedative agents in addition to Midazolam\n\nRefusal of parental or guardian consent'}, 'identificationModule': {'nctId': 'NCT07438834', 'briefTitle': 'Continuous Sedation vs Daily Sedation Interruption in Ventilated Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Comparison of Comfort Scores Between Continuous Midazolam Infusion and Daily Sedation Interruption in Mechanically Ventilated Pediatric Patients With Pneumonia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Exp135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Sedation Infusion (CSI)', 'interventionNames': ['Other: Continuous Sedation Infusion (CSI)']}, {'type': 'EXPERIMENTAL', 'label': 'Daily Sedation Interruption (DSI)', 'interventionNames': ['Other: Daily Sedation Interruption (DSI)']}], 'interventions': [{'name': 'Continuous Sedation Infusion (CSI)', 'type': 'OTHER', 'description': 'Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.', 'armGroupLabels': ['Continuous Sedation Infusion (CSI)']}, {'name': 'Daily Sedation Interruption (DSI)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Daily Sedation Interruption (DSI)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dr. Shamshad Shinwari', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}