Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04483869
Status:
UNKNOWN
Last Update Posted:
2020-07-27
First Post:
2020-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infrared Thermography and Apgar Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013817', 'term': 'Thermography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D062125', 'term': 'Thermometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thermographic image', 'timeFrame': '1 minute of life', 'description': 'Correlation between thermographic image and Apgar score'}, {'measure': 'thermographic image', 'timeFrame': '5 minutes of life', 'description': 'Correlation between thermographic image and Apgar score'}, {'measure': 'thermographic image', 'timeFrame': '10 minutes of life', 'description': 'Correlation between thermographic image and Apgar score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thermography', 'apgar score'], 'conditions': ['Newborn, Transient']}, 'descriptionModule': {'briefSummary': "Background: The Apgar score assesses the newborn's adaptation in the first minutes of life. It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar score at 5 minutes of life is associated with increased neonatal mortality and neurological impairment. However, this score has limitations and its measurement remains subjective: it does not guide resuscitation actions in the event of poor adaptation, significant inter-observer variability in scoring, variations according to the physiological maturation of the newborn, in particular according to gestational age.\n\nInfrared thermography is a rapidly developing imaging technique based on the measurement of infrared radiation. It is an accurate, reliable and easy instrument of providing rapid non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal intensive care unit for early diagnosis of certain pathologies such as infection. During the transition, during the first minutes of life, the circulatory and respiratory systems of the newborn change. Vasodilatation occurs progressively in the central and peripheral areas. Thermoregulation is also a crucial stage of adaptation.\n\nIn view of this physiopathological knowledge, it seems interesting to correlate this adaptation , with the analysis of thermographic images. The principle of this technique is indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate the blood perfusion of the newborn, and its evolution in the first minutes of life in an objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on photographs taken at time T, contrary to the calculation of the Apgar score for which there are several limitations mentioned above.\n\nMain objective of the study: To study the ability of the thermographic image to objectively evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar, pH, Lactates)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term newborn, born after cesarean delivery, without congenital anomalies', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term infants, gestational age ≥ 37 weeks of gestation\n* cesarean delivery\n* maternal age ≥ 18 years\n\nExclusion Criteria:\n\n* parents refusal\n* congenital anomalies'}, 'identificationModule': {'nctId': 'NCT04483869', 'acronym': 'VIRGINA', 'briefTitle': 'Infrared Thermography and Apgar Score', 'organization': {'class': 'OTHER', 'fullName': 'Poissy-Saint Germain Hospital'}, 'officialTitle': 'Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn', 'orgStudyIdInfo': {'id': '2020-A00265-34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thermography', 'type': 'OTHER', 'description': 'thermographic image a 1, 3, 5 et 10 minutes of life'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78300', 'city': 'Poissy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde P. Letouzey, MD', 'role': 'CONTACT', 'email': 'mathilde.letouzey@gmail.com', 'phone': '+33139274430'}], 'facility': 'Poissy Saint Germain Hospital', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poissy-Saint Germain Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mathilde Letouzey, MD', 'investigatorAffiliation': 'Poissy-Saint Germain Hospital'}}}}