Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 1:08 AM
Study NCT ID:
NCT05192668
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Setting and Effect Evaluation of QT in NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean weekly gain in weight of VLBWIs', 'timeFrame': 'From the day the VLBWI admitted to the day VLBWI discharged, about two months.', 'description': 'The average weekly gain in weight of VLBWIs in the intervention group minus the average weekly gain in weight of VLBWIs in the control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quiet Time', 'Weight'], 'conditions': ['Very Low Birth Weight Infant']}, 'descriptionModule': {'briefSummary': 'In order to create a better environment for growth and development for very low birth weight infants(VLBWIs), investigators introduce quiet time, which is an intervention method that reduces environmental noise in the ward and centralizes medical and nursing operations. By analyzing the weight gain of VLBWIs in the intervention group and the control group during hospitalization, the effect of setting a quiet time in the NICU on improving the growth and development of VLBWIs is evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight \\<1500g;\n* Admit within 24 hours of birth;\n* The guardian signs the informed consent.\n\nExclusion Criteria:\n\n* Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;\n* Newborn who do not achieve discharge or death at the end of the study period.'}, 'identificationModule': {'nctId': 'NCT05192668', 'briefTitle': 'The Setting and Effect Evaluation of QT in NICU', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'The Setting and Effect Evaluation of Quiet Time in Neonatal Intensive Care Unit', 'orgStudyIdInfo': {'id': '[2021]296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quiet time care', 'description': 'Reduce noise and centralize medical or nursing operations in the NICU', 'interventionNames': ['Other: Quiet time care']}, {'type': 'NO_INTERVENTION', 'label': 'Routine nursing care', 'description': 'Perform routine nursing care for the VLBWIs in the NICU'}], 'interventions': [{'name': 'Quiet time care', 'type': 'OTHER', 'description': 'This study is a non-self before and after control study. The data of VLBWIs in the control group is collected in the early stage, and the quiet time intervention is carried out in the later period, and the data of VLBWIs in the intervention group is collected', 'armGroupLabels': ['Quiet time care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}