Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT02844205
Status:
UNKNOWN
Last Update Posted:
2016-09-01
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of a New Practical Newborn Behavioral Observation Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of the external reproductibility of a new practical newborn behavioral observation scale', 'timeFrame': 'up to 1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nursing care', 'observational scale', 'neonate', 'premature infant', 'developmental care'], 'conditions': ['Premature Newborn']}, 'descriptionModule': {'briefSummary': 'Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.\n\nHowever, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.\n\nA new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.\n\nThe goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infant hospitalized in intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term of birth between 24 and 33 weeks of amenorrhea\n* weight less than 1500g birth;\n* postnatal age between 1 and 60 days\n* consent form of parent in order to film their baby\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02844205', 'briefTitle': 'Reproducibility of a New Practical Newborn Behavioral Observation Scale', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program', 'orgStudyIdInfo': {'id': '9589'}}, 'armsInterventionsModule': {'interventions': [{'name': 'quotation of the newborn behavioral observation scale', 'type': 'OTHER', 'description': 'quotation of the newborn behavioral observation scale by 12 experimented nurses. Patient will be filmed during an usual care and nurses will quote the scale thanks to the video.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles Cambonie, Professor', 'role': 'CONTACT', 'email': 'g-cambonie@chu-montpellier.fr'}], 'facility': 'University hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'gille Cambonie, Professor', 'role': 'CONTACT', 'email': 'g-cambonie@chu-montpellier.fr'}], 'overallOfficials': [{'name': 'Gilles Cambonie, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}