Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT05246150
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIRS Levels of Infants in Neonatal Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nursing practices', 'timeFrame': '24 hours', 'description': 'Change of nursing practices on Near Infrared Spectroscopy levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU).\n\nMaterials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart." The data were evaluated with the IBM SPSS 24 package program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '40 premature newborns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates younger than a gestational age of 37 weeks\n* Those monitored in an open or closed incubator\n\nExclusion Criteria:\n\n* Intubated neonates connected to a mechanical ventilator\n* Infants of a gestational age of 37 weeks or more\n* Infants under sedation\n* Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)'}, 'identificationModule': {'nctId': 'NCT05246150', 'briefTitle': 'NIRS Levels of Infants in Neonatal Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'The Effect Of Nursıng Practıces On The Near Infrared Spectroscopy Levels Of Premature Infants', 'orgStudyIdInfo': {'id': 'EsksehirOU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infants receiving nursing care', 'interventionNames': ['Behavioral: nursing care practices']}], 'interventions': [{'name': 'nursing care practices', 'type': 'BEHAVIORAL', 'description': 'To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies', 'armGroupLabels': ['infants receiving nursing care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26000', 'city': 'Eskişehir', 'country': 'Turkey (Türkiye)', 'facility': 'Eskisehir', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NURSE', 'investigatorFullName': 'Ezgi Ayvaz', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}