Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT03651258
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'age at the stoppage of enteral nutrition', 'timeFrame': '37 weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'Duration of feeding', 'timeFrame': '37 weeks of gestation', 'description': 'Duration of the feeding in case of early game play'}, {'measure': 'Quantities drunk', 'timeFrame': '37 weeks of gestation', 'description': 'Evaluate the quantities drunk in case of early game play'}, {'measure': 'Awakening', 'timeFrame': '37 weeks of gestation', 'description': "Duration of the the newborn's waking state at the time of suckling"}, {'measure': 'Visual analogic scale for Satisfaction from 0 to 10', 'timeFrame': '37 weeks of gestation', 'description': 'Assessing the satisfaction of the ALIJEU practice for the mother and the care team'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feeding Behavior'], 'conditions': ['Immature Newborn', 'Feeding Behavior']}, 'descriptionModule': {'briefSummary': 'The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premate newborn with an age inferior to 32 weeks of amenorrhea at birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of child at birth: \\<32 WA justified by the greater prevalence of oral disorders in these children.\n* Age of the child at the start of the study: 35 WA, ie at the beginning of the establishment of active feeding within the unit.\n\nExclusion Criteria:\n\n* Children with oral malformations\n* Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)\n* Medical contraindications to oral diet'}, 'identificationModule': {'nctId': 'NCT03651258', 'acronym': 'ALIJEU', 'briefTitle': 'Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play', 'orgStudyIdInfo': {'id': 'ALIJEU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'patient who can benefit from the ALIJEU for certain meals', 'interventionNames': ['Behavioral: Implementation of ALIJEU']}, {'label': 'Group of witnesses', 'description': 'patient who did not benefit from the ALIJEU'}], 'interventions': [{'name': 'Implementation of ALIJEU', 'type': 'BEHAVIORAL', 'description': 'The intervention concerns the passage from the passive feed (gastric tube) to the active feed (breast, feeding bottle).\n\nWe propose to set up a pleasant moment just before his meal. This is a practical exercise of a few minutes.\n\nThe aim of this special moment is to facilitate child-adult exchanges, improve active food intake and reduce the length of hospital stay.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CHI Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}