Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05167318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of of bacterial in the oral cavity', 'timeFrame': 'weekly for 4 weeks', 'description': 'microbial analysis of the oral microbiome'}], 'secondaryOutcomes': [{'measure': 'Days of respiratory support', 'timeFrame': 'Up to 100 days', 'description': 'number of days infant was on respiratory support'}, {'measure': 'Incidence of chronic lung disease', 'timeFrame': 'Up to 100 days', 'description': 'Whether or not the infant was diagnosed with chronic lung disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microbial Colonization', 'Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'minimumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\< 32 weeks\n* birth weight \\< 1500 grams\n* mother is English speaking\n* mother is \\> 18 years of age.\n\nExclusion Criteria:\n\n* Congenital anomalies of the face, lungs, or gastrointestinal system\n* not expected to survive'}, 'identificationModule': {'nctId': 'NCT05167318', 'briefTitle': 'Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit', 'orgStudyIdInfo': {'id': 'IRB202101340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'every 3-4 hour oral care', 'description': 'Infants will receive standardized oral care every 3-4 hours for 4 weeks', 'interventionNames': ['Other: frequent standardized oral care']}, {'type': 'NO_INTERVENTION', 'label': 'every 12 hour oral care', 'description': 'Infants will receive standardized oral care every 12 hours for 4 weeks'}], 'interventions': [{'name': 'frequent standardized oral care', 'type': 'OTHER', 'description': 'Standardized oral care will be provided every 3-4 hours', 'armGroupLabels': ['every 3-4 hour oral care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Leslie Parker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}