Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-27 @ 6:38 AM
Study NCT ID:
NCT04548050
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '104/5000 Percentage of mothers who expressed colostrum before 24hours', 'timeFrame': '24hours after childbirth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Breastfeeding']}, 'descriptionModule': {'briefSummary': "Colostrum is an irreplaceable nutrient rich in protein and antibodies. Its taste and smell are similar to those of amniotic fluid (therefore rich for the senses of the baby separated from his mother). It should be offered to every newborn baby, regardless of term and the type of breastfeeding their mom wants. The early expression of colostrum, within the first 2 hours after childbirth, is an essential way to start lactation of a mother separated from her baby. The sooner and more often the mother stimulates her breasts, the more milk she will have for her baby in the weeks to come. Manual expression of milk is therefore an essential gesture to initiate lactation, maintain it, and giving colostrum to babies as early as possible is beneficial. Two studies carried out in the neonatal medicine department of Felix Guyon Hospital in premature infants \\<33 week of amenorrhea (PRE'OLACT study in 2015-2016 by Dr RAJAOFERA and Diploma from university (DU) breastfeeding brief in 2018-2019 by Dr GRONDARD) found the same results: the desire for breastfeeding is 80% but manual expression of colostrum before H24 is only achieved by 30% of mothers and before H6 in only 6% of cases.\n\n."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the CHU - Félix GUYON .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All mothers, over 18 years of age, of newborns hospitalized in neonatal medicine at the University Hospital Center (CHU) - Félix GUYON Hospital during the study period.\n* Expressed no opposition from mothers to their participation and to the use of their data\n\nExclusion Criteria:\n\n* Outborn\n* Mother not hospitalized in the maternity ward of Félix Guyon Hospital\n* Prognosis for the child engaged in the first 24 hours\n* Difficult oral comprehension\n* Medical contraindication to breastfeeding\n* Unseen mother \\<3D'}, 'identificationModule': {'nctId': 'NCT04548050', 'acronym': 'ORLIKID', 'briefTitle': 'Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine', 'orgStudyIdInfo': {'id': '2020/CHU/26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mothers informed by untrained nurse'}, {'label': 'mothers informed by trained nurse', 'interventionNames': ['Other: Nurses training']}, {'label': 'mothers informed by nurses trained 6 months ago', 'interventionNames': ['Other: Nurses training']}], 'interventions': [{'name': 'Nurses training', 'type': 'OTHER', 'description': '* Presentation of the benefits of colostrum and manual expression technique on a slide show and practical workshops for learning the manual expression technique on a fictitious breast.\n* Presentation to all staff of a service protocol for early colostrum donation.', 'armGroupLabels': ['mothers informed by nurses trained 6 months ago', 'mothers informed by trained nurse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97400', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de la Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}