Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-09 @ 12:56 PM
Study NCT ID:
NCT06543433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study
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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The intervention will be given to all participants and the investigators will test how many hours of SSC per day the parents can achieve.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-08-03', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hours of SSC per day', 'timeFrame': 'In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).', 'description': 'primary neonatal outcome will be hours of SSC per day'}, {'measure': 'Parental Stress Scale (PSS) NICU', 'timeFrame': '4 to 7 days after birth.', 'description': 'Parental Stress Scale (PSS) NICU performed by the mother. Minimum and maximum values for PSS NICU are 0 and 72, higher scoring indicates higher parental stress.'}], 'secondaryOutcomes': [{'measure': 'Time outside of temperature range 36.5-37.5', 'timeFrame': 'In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).', 'description': 'Time outside of temperature range 36.5-37.5 measured axillary'}, {'measure': 'time in environmental humidity of less than 60%', 'timeFrame': 'In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).', 'description': 'time in environmental humidity of less than 60% measured by hygrometer and incubator hygrometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the feasibility of using the Skincubator, a wearable incubator for skin to skin contact of preterm babies and their parents. It will also learn about the safety of skincubator. The main questions it aims to answer are:\n\n* Can the Skincubator keep a stable temperature for the smallest babies and the first days after birth?\n* How many hours will the parents (and other family members) will succeed to perform skin to skin every day?\n\nParticipants will:\n\nBe offered the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment.', 'detailedDescription': 'Study design: This is a non-randomized feasibility trial with no control group in which the investigators will offer parents the option to perform Skincubator care - being cared for in SSC inside the Skincubator, which is placed on the mother and/or another caregiver. Skincubator care will be provided from birth if the caring team and the parents feel it is appropriate. The option for Skincubator care will be provided for as long as the parents, surrogates, and staff feel comfortable with a goal of possible achievement of the WHO target of 8 hours per day. Each infant will participate in the study for one week from enrollment (If parents desire, they will be able to continue using the Skincubator beyond 1 week as long as NICU staff feel that it is helpful for the baby).\n\nImplementation phase: Prior to beginning the study, each center will provide care in the Skincubator for five noninvasively ventilated preterm babies. After gaining experience in treating a preterm baby in the Skincubator and performing manikin simulations of Skincubator care for invasively ventilated babies, the NICU team in each center will be able to decide whether to include intubated babies in the trial.\n\nPopulation: up to 25 preterm neonates in each site, born at GA of 24.0-32.6 with birth weight of \\<1.5 kg.\n\nFirst 3 babies will be of GA of 26-32.6 and on noninvasive respiratory support. Those babies will be considered a learning phase for the team, and may be analyzed separately. After completing the learning phase the study will proceed with 4 groups:\n\n1. Up to 7 more babies of GA of 26-32.6 and on noninvasive respiratory support.\n2. 5 Intubated babies with GA of 26-32.6. The investigators will start enrolling babies from this group only after the team treated at least 5 babies from group 1 (including the learning phase) and feels ready to move on to intubated babies.\n3. 5 babies GA 24.0-25.6 on noninvasive respiratory support. The investigators will start enrolling babies from this group only after the team treated at least 5 babies from group 1 (including the learning phase) and feels ready to move on to this age group.\n4. 5 intubated babies with GA of 24.0-25.6. The investigators will start enrolling babies from this group only after the team treated at least 3 babies from group 2 and 3 babies from group 3, and only if the team feels ready to move on to this group also.\n\nFirst five babies will be treated in the Skincubator only from NICU admission. After gaining experience with the first 5 babies the team may decide to start Skincubator care in birth suite (ideally on the mother, potentially on the father if the mother prefers or is feeling unwell) or in cesarean section theater (on the father).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates with birth weight of \\<1.5 kg\n* Requiring respiratory support\n* Cared for in an incubator with at least 60% humidity.\n\nExclusion Criteria:\n\n* Critical congenital heart disease\n* Suspected genetic syndrome\n* Hemodynamic instability\n* Having a chest tube,\n* Significant congenital anomalies,\n* Need for surgery\n* If the attending neonatologist decides that the Skincubator is not safe for a specific baby.\n* Neonates whose mothers have a significant mental disorder that is not adequately controlled\n* Neonates of parents unable to perform extended SSC for any reason will be excluded as well.'}, 'identificationModule': {'nctId': 'NCT06543433', 'briefTitle': 'Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Skincubator (Model 2), a Novel Incubator for Skin to Skin Contact Feasibility Study, in Monash and Riverside', 'orgStudyIdInfo': {'id': 'V1 15.5.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skincubator', 'description': 'This is the only arm. All babies in trial will receive the intervention.', 'interventionNames': ['Device: Skincubator 2']}], 'interventions': [{'name': 'Skincubator 2', 'type': 'DEVICE', 'description': "The Skincubator is a small incubator designed to attach to the caregiver's torso without any barrier between the parent's chest and the baby. It creates an environment with the advantages of a standard neonatal incubator, while enabling Skin to Skin contact for extended periods from birth. It has multiple access points, to allow for common nursing procedures. It is anchored safely to the parent's body and secures ventilator and IV tubing. It also includes side ports for the parents to insert their hands to touch their baby.\n\nThe investigators will offer the parents in the intervention group the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment. The investigators will provide the parents with the aids to accomplish this goal: the Skincubator system with a convenient environment, the option for Skincubator surrogates and, where possible, the option for one of the parents to sleep with the baby safely secured in the Skincubator.", 'armGroupLabels': ['Skincubator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Calum Roberts, M.D', 'role': 'CONTACT', 'email': 'calum.roberts@monash.edu', 'phone': '+61 3 8572 3657'}, {'name': 'Calum Roberts, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Monash Children's hospital", 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'centralContacts': [{'name': 'Itamar Nitzan, M.D', 'role': 'CONTACT', 'email': 'itamarnitzan@gmail.com', 'phone': '+972507414998'}, {'name': 'Alon Metrikin Gold', 'role': 'CONTACT', 'email': 'alon@skincubator-neocare.com'}], 'overallOfficials': [{'name': 'Itamar Nitzan, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators will need to discuss with local IRBs'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Itamar Nitzan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Monash University', 'class': 'OTHER'}, {'name': 'Monash Health', 'class': 'OTHER'}, {'name': 'Riverside University Health System Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Itamar Nitzan', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}