Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT06626594
Status:
WITHDRAWN
Last Update Posted:
2024-11-25
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'This study, part of the NCT06573203 study, used the same ethical approval and should not have been reregistered or withdrawn.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal sleep-wake state scores（composite outcome measure）', 'timeFrame': 'Results observed within 2 minutes.', 'description': 'Behavioral state 4 items each scored and total score.The Chinese version of the Neonatal Sleep-Wake Assessment Tool included 4 items: eyes, breathing, facial expression, and movement. Each item was scored from 0 to 2 points, and the total score was from 0 to 8 points.Less than 3 points was defined as quiet sleep, 3-6 points as active sleep, and more than 6 points as awake sleep.'}], 'secondaryOutcomes': [{'measure': 'Sleep state as shown by Amplitude-integrated EEG', 'timeFrame': 'Measurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.', 'description': 'The sleep-wake state of the newborn was obtained by aEEG analysis.The spectrum band of aEEG can be analyzed that the newborn is in a quiet sleep state, an active sleep state and an awake state. Generally, the narrow band refers to the awakening period and AS period, and the broad band refers to the QS period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Newborn Health']}, 'descriptionModule': {'briefSummary': 'Sleep assessment of newborns in China is often neglected by medical staff, but sleep is related to the stability of vital signs and future neurobehavioral development. In order to understand the sleep quality of Chinese newborns and to protect their sleep during work, the neonatal sleep-wake assessment tool was translated into Chinese, revised, and tested for reliability and validity, in order to provide a reference for clinical staff to choose the timing of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All neonates admitted to the department of Neonatology and neonatal intensive care unit who met the definition of newborn.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The clinical definition of a newborn was met.\n\nExclusion Criteria:\n\n* A state of persistent convulsions'}, 'identificationModule': {'nctId': 'NCT06626594', 'briefTitle': 'Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool', 'organization': {'class': 'OTHER', 'fullName': "The Children's Hospital of Zhejiang University School of Medicine"}, 'officialTitle': 'Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool', 'orgStudyIdInfo': {'id': '2024-IEC-0024-P-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients enrolled', 'description': 'All patients admitted to the neonatology department and neonatal intensive care unit were assessed for behavioral status using the Chinese version of the Neonatal Sleep-Wake Assessment Tool. Sleep cycles were also monitored using an electroencephalogram.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'CHZhejiang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Director of Nursing Department', 'investigatorFullName': 'Shujun Li', 'investigatorAffiliation': "The Children's Hospital of Zhejiang University School of Medicine"}}}}