Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-03-01 @ 9:41 PM
Study NCT ID:
NCT02769468
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average temperature right axillary.', 'timeFrame': '1 year', 'description': 'The average temperature axillary at the admission in the Neonatal intensive care unit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Temperature-Probe Placement-preterm infant-case room'], 'conditions': ['Body Temperature Changes']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of 3 different skin temperature placement probe in the case room on the admission temperature to the NICU in preterm infants. The authors aim to evaluate which placement results in more preterm in the acceptable range (36.5-37 °C).', 'detailedDescription': "It's a prospective randomized trial conducted at Maisonneuve Rosemont Hospital, neonatal tertiary center located in Montreal with over 2600 annual deliveries. All pregnant women who are expecting to deliver a preterm infant with gestational between 28 and 35 6/7 weeks will be eligible to be enrolled into the study and informed consent is obtained.\n\nSimple randomization is accomplished by opening a sealed pre-set envelope with group assignment before delivery.\n\nGroup 1: The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.\n\nGroup 2: The probe is placed on the chest, 1 cm above the left nipple. Group 3: The probe is placed deep in the left axilla\n\nAt birth, all the preterm are immediately placed under a radiant warmer and resuscitated as per Neonatal resuscitation program (NRP) guidelines. Application of a skin temperature probe set at 36.5°C, for servo-controlled thermoregulation by 2 minutes of life. Probes will be fixed with an insulated reflective water-soluble gel probe.\n\nNo changes are made to the routine delivery room management and resuscitation for this study. After initial delivery room management, babies are transported in a heated radiant warmer (Panda) to the NICU.\n\nIn the delivery room, when the baby has a skin temperature servo-controlled stable at 36.5° C, the baby is ready to be transferred to NICU. All babies admitted to the NICU are routinely cared for by the attending neonatologist.\n\nData collection:\n\nThe temperature displaced on the servo controlled table is collected when the baby is the NICU just before transfer from the radiant table to the incubator.\n\nThe right axillary temperature will be taken by a thermometer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Preterm infant with gestational age between 28 and 35 6/7 weeks\n\nExclusion criteria:\n\n* Infant with severe congenital malformation and those who had sever asphyxia or died in the delivery room and infant born before arrival of NICU team.'}, 'identificationModule': {'nctId': 'NCT02769468', 'briefTitle': 'Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants?', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Effect of Temperature Probe Placement in Delivery Room on Temperature at the Admission in the Neonatal Intensive Care Unit (NICU) of Premature Infants?', 'orgStudyIdInfo': {'id': '15052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The Back', 'description': 'The probe is placed lateral from the spine, 1 cm above the intergluteal cleft, and in side position to the flank between the hips and the ribs.', 'interventionNames': ['Other: The Back']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chest', 'description': 'The probe is placed on the chest, 1 cm above the left nipple.', 'interventionNames': ['Other: Chest']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left Axilla', 'description': 'The probe is placed deep in the left axilla', 'interventionNames': ['Other: Left Axilla']}], 'interventions': [{'name': 'The Back', 'type': 'OTHER', 'armGroupLabels': ['The Back']}, {'name': 'Chest', 'type': 'OTHER', 'armGroupLabels': ['Chest']}, {'name': 'Left Axilla', 'type': 'OTHER', 'armGroupLabels': ['Left Axilla']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Brahim Bensouda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Assistant Professor', 'investigatorFullName': 'Dr Brahim Bensouda', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}