Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 3:47 AM
Study NCT ID:
NCT03450668
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2018-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mOm Incubator Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 580919, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-05-20T12:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Choice of incubator used is randomized and blinded until the subject has been recruited and incubator arm assigned. After which it will be known to all concerned.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'a randomized two-arm crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thermo-regulation', 'timeFrame': '24 hours', 'description': 'ability of incubator to maintain stable temperature of baby'}], 'secondaryOutcomes': [{'measure': 'Usability', 'timeFrame': '24 hours', 'description': 'Time to prepare for use and clean incubator (in-use cleaning and deep clean between use)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal, incubator, thermal-regulation'], 'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks gestational age and require at least 48 hours incubator care. A standard or test incubator will be used for the first 24 hours chosen randomly, then the baby will be moved to the over arm for a further 24 hours.', 'detailedDescription': "Investigators will recruit babies who are in the Neonatal Unit at St. Peter's Hospital. Babies will be clinically stable from a cardio-respiratory point of view. They will also be requiring incubator care (so they will weigh less than approximately 1400g) but not requiring additional humidification. This effectively excludes babies born less than 30 weeks gestation who are routinely humidified for the first week (if 28-30 weeks gestation) or two weeks (if less than 28 weeks gestation). Some term babies may also be eligible for the study if they are being nursed in an incubator for clinical reasons.\n\nIdentification and recruitment of babies will be carried out by the attending Consultant Neonatologist and the research team.\n\nFor twins, consecutive enrolment will be possible if only one mOm incubator is available.\n\nThere will be two arms to the protocol. The first arm will consist of standard incubator care, where the care of the baby is unchanged, but non-invasive, more frequent (hourly) temperature and other physiological measures of stability than would normally be collected in routine care (nominally every three hours) will be collected. The second arm will be the baby receiving normal care in the mOm incubator, with another set of hourly detailed, non-invasive, observations. The planned care and monitoring of the baby will be otherwise unchanged. No additional blood tests or any other invasive testing or monitoring are required. The clinical team will have full control and responsibility for the baby's care and can terminate the study for the baby at any time for any reason.\n\nIn addition, investigators will collect the views of staff on the baby's comfort, visibility, care, usability and acceptability during each arm of the study.\n\nFor each arm of the study, the secondary outcome measures are:\n\n(1) pulse rate (as a measure of clinical stability) (2) respiratory rate (as a measure of clinical stability) (3) apnea and bradycardia episodes recorded by nursing staff (clinical stability) (4) temperature (as a measure of clinical stability) (4) adverse events related to incubator performance (5) cleaning ease and time took (6) set up time (7) staff structured feedback\n\n36 eligible babies will be recruited into the study at a single site, being identified by the clinical team. All 36 will experience a 24 hour period in each of the two incubators (mOm and standard) (48 hours in total), in a randomly allocated order. Babies will act as their own controls in this cross-over study design. If any babies fail to complete the 48-hour study procedures (e.g. due to data incomplete or baby withdrawn) further babies will be recruited to achieve 36 complete datasets."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 30 weeks gestational age and less than or equal to 6kg\n* In need of at least 48 hours incubation in a stable temperature environment\n* Must be clinically stable\n* Parental/legal guardian written informed consent has been given\n\nExclusion Criteria:\n\n* Does not require humidity regulation\n* Parent/legal guardian must not be from a vulnerable group'}, 'identificationModule': {'nctId': 'NCT03450668', 'briefTitle': 'mOm Incubator Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'mOm incubators'}, 'officialTitle': 'Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback', 'orgStudyIdInfo': {'id': 'mOm/2018/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard incubator', 'description': 'routinely used standard incubator already used in the neonatal unit', 'interventionNames': ['Device: mOm incubator', 'Device: standard incubator']}, {'type': 'EXPERIMENTAL', 'label': 'mOm incubator', 'description': 'new test incubator', 'interventionNames': ['Device: mOm incubator', 'Device: standard incubator']}], 'interventions': [{'name': 'mOm incubator', 'type': 'DEVICE', 'description': '24 hour usage of test incubator', 'armGroupLabels': ['mOm incubator', 'standard incubator']}, {'name': 'standard incubator', 'type': 'DEVICE', 'description': 'standard incubator', 'armGroupLabels': ['mOm incubator', 'standard incubator']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT16 0PZ', 'city': 'Chertsey', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': "Ashford and St. Peter's Hospital", 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mOm incubators', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}