Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT06399861
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humidity in Incubators for Tiny Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average total pre-discharge costs', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)', 'description': 'Total pre-discharge costs (assessed from the health system perspective) encompass facility costs and professional service costs.'}], 'primaryOutcomes': [{'measure': 'Efficacy as assessed by percent of birth weight lost', 'timeFrame': 'upon admission to the NICU, postnatal week 2'}, {'measure': 'Composite safety score', 'timeFrame': 'from time of admission to the NICU through hospital discharge (about 4-5 months)', 'description': 'A single composite safety score will be reported (mortality and 6 morbidities will be assessed to determine this score). The composite score ranges from 0 to 7, with a higher score indicating a better outcome, as listed below:\n\n* 0 = Infant does not survive\n* 1 = Infant survives, has all 6 assessed morbidities\n* 2 = Infant survives, has 5 assessed morbidities\n* 3 = Infant survives, has 4 assessed morbidities\n* 4 = Infant survives, has 3 assessed morbidities\n* 5 = Infant survives, has 2 assessed morbidities\n* 6 = Infant survives, has 1 assessed morbidities\n* 7 = Infant survives, has no assessed morbidities\n\nMorbidities assessed:\n\n* grade III-IV intraventricular hemorrhage (IVH)\n* surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)\n* grade III bronchopulmonary dysplasia (BPD)\n* treated retinopathy of prematurity (ROP)\n* culture-proven late-onset sepsis (LOS)\n* patent ductus arteriosus (PDA) ligation'}], 'secondaryOutcomes': [{'measure': 'Average axillary temperatures in degrees Celsius (°C)', 'timeFrame': 'from time of admission to the NICU to postnatal day 3'}, {'measure': 'Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily weight in grams', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Average daily protein administered in grams per kilogram per day (g/kg/d)', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Number of participants who were administered insulin', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Number of participants who were administered vasopressor', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}, {'measure': 'Weight', 'timeFrame': '36 weeks postmenstrual age'}, {'measure': 'Length', 'timeFrame': '36 weeks postmenstrual age'}, {'measure': 'Head circumference', 'timeFrame': '36 weeks postmenstrual age'}, {'measure': 'Number of participants who survive to hospital discharge', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with grade III bronchopulmonary dysplasia (BPD)', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with treated retinopathy of prematurity [ROP]', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with culture-proven late-onset sepsis (LOS)', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of participants with patent ductus arteriosus (PDA) ligation', 'timeFrame': 'from time of admission to the NICU to discharge (about 4-5 months)'}, {'measure': 'Number of unplanned removals of vascular access or breathing tube', 'timeFrame': 'from time of admission to the NICU to postnatal day 14'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Humidification Protocol'], 'conditions': ['Extremely Premature Infant']}, 'descriptionModule': {'briefSummary': "The objective of the study is to assess 2 different initial incubator humidification protocols for infants \\<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inborn infant of \\<25 weeks' gestation admitted to the NICU\n\nExclusion Criteria:\n\n* Infants with known congenital skin conditions\n* Outborn infants\n* Infants with unknown gestational age prior to birth"}, 'identificationModule': {'nctId': 'NCT06399861', 'acronym': 'HumidITI', 'briefTitle': 'Humidity in Incubators for Tiny Infants', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Humidity in Incubators for Tiny Infants (HumidITI) Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Incubator ambient relative humidity (RH) of 70%', 'description': 'Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 70% in the incubator.', 'interventionNames': ['Device: Incubator ambient relative humidity (RH) of 70%']}, {'type': 'EXPERIMENTAL', 'label': 'Incubator ambient relative humidity (RH) of 90%', 'description': 'Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 90% in the incubator.', 'interventionNames': ['Device: Incubator ambient relative humidity (RH) of 90%']}], 'interventions': [{'name': 'Incubator ambient relative humidity (RH) of 70%', 'type': 'DEVICE', 'description': 'The incubator will be set to an ambient relative humidity (RH) of 70%.', 'armGroupLabels': ['Incubator ambient relative humidity (RH) of 70%']}, {'name': 'Incubator ambient relative humidity (RH) of 90%', 'type': 'DEVICE', 'description': 'The incubator will be set to an ambient relative humidity (RH) of 90%.', 'armGroupLabels': ['Incubator ambient relative humidity (RH) of 90%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carl Backes, MD', 'role': 'CONTACT', 'email': 'Carl.Backes@nationwidechildrens.org', 'phone': '614-722-2000'}, {'name': 'Carl Backes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital - Grant Medical Center", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carl Backes, MD', 'role': 'CONTACT', 'email': 'Carl.Backes@nationwidechildrens.org', 'phone': '614-293-8000'}, {'name': 'Carl Backes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital - Ohio State University Wexner Medical Center", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew A. Rysavy, MD, PhD', 'role': 'CONTACT', 'email': 'Matthew.A.Rysavy@uth.tmc.edu', 'phone': '713-500-5651'}, {'name': 'Matthew Rysavy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaashif Ahmad, MD', 'role': 'CONTACT', 'email': 'kahmad@uh.edu'}, {'name': 'Kaashif Ahmad, MD, Mac', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Woman's Hospital of Texas", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Aune, MD', 'role': 'CONTACT', 'email': 'Christine_Aune@mednax.com', 'phone': '210-297-5000'}, {'name': 'Christine Aune, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Baptist Hospital", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brent Rayburn, MD', 'role': 'CONTACT', 'email': 'brent.reyburn@pediatrix.com', 'phone': '210-297-4000'}, {'name': 'Brent Rayburn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Central Baptist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Matthew A. Rysavy, MD, PhD', 'role': 'CONTACT', 'email': 'Matthew.A.Rysavy@uth.tmc.edu', 'phone': '713-500-5651'}], 'overallOfficials': [{'name': 'Matthew A. Rysavy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew Rysavy', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}