Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-04-03 @ 11:44 PM
Study NCT ID:
NCT02211404
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children's Sleep in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time', 'timeFrame': '24 Hours'}]}, 'conditionsModule': {'conditions': ['Children Admitted to the Intensive Care Unit']}, 'descriptionModule': {'briefSummary': "Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children admitted to the Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU\n* Age from 0 days to 17 years 364 days at the time of enrollment\n* Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours duration\n\nExclusion Criteria:\n\n* Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure Disorder, Severe Developmental Delay that might impair normal sleep architecture, Known abnormal EEG, any patient actively receiving Mechanical Ventilation'}, 'identificationModule': {'nctId': 'NCT02211404', 'briefTitle': "Children's Sleep in the ICU", 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': '13-00326'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'James Hungerford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James Hungerford', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}