Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 6:02 AM
Study NCT ID:
NCT04233333
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2020-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixation of the Orogastric Tube: Which Method for the Newborn ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average duration of holding the fixation', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': "Number of tube's dislodgements", 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Feeding', 'Gastric Emptying']}, 'descriptionModule': {'briefSummary': 'It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn\'s cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.\n\nTo achieve a more sustainable orogastric tube\'s fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube\'s fixing technique that was subsequently approved and used.\n\nUsing this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe\'s fixation method to the mustache.\n\nThe aim of the study is to ensure a more effective orogastric tube\'s fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns admitted to neonatal intensive care unit\n* Express consent of the holders of parental authority\n* Orogastric tube indication (enteral feeding, digestive aspiration)\n\nExclusion Criteria:\n\n* Newborns over 2 months of age corrected\n* Indication of nasogastric tube\n* Port of gastrostomy\n* Pathology resulting in hypersalivation or hyper sweating\n* Swallowing disorder\n* Genetic disease\n* Severe neurological impairment\n* Cleft lip and / or palate\n* Other malformation in the oral sphere or perioral area\n* Sedation with morphine analgesics\n* Anticonvulsant treatment\n* Palliative care'}, 'identificationModule': {'nctId': 'NCT04233333', 'acronym': 'BABAFIX', 'briefTitle': 'Fixation of the Orogastric Tube: Which Method for the Newborn ?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Fixation of the Orogastric Tube: Which Method for the Newborn ?', 'orgStudyIdInfo': {'id': '2017/CHU/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mustache fixation', 'interventionNames': ['Device: method of fixation of the orogastric tube']}, {'type': 'EXPERIMENTAL', 'label': 'W.K fixation', 'interventionNames': ['Device: method of fixation of the orogastric tube']}], 'interventions': [{'name': 'method of fixation of the orogastric tube', 'type': 'DEVICE', 'description': 'Methods of fixation of the orogastric tube will be randomized', 'armGroupLabels': ['W.K fixation', 'mustache fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97448', 'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT'}, {'name': 'Sylvie PAYET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de la Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}], 'centralContacts': [{'name': 'Lucie AUZANNEAU', 'role': 'CONTACT', 'email': 'lucie.auzanneau@chu-reunion.fr', 'phone': '(0)262 35 99 49', 'phoneExt': '+262'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}