Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT03693651
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}], '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'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scale Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '6 months from child Birth', 'description': 'Online self-report questionnaire that assesses sleep quality filled at 1 month, 3 months and 6 months from child birth.\n\nThis questionnaire has been validated to assess the presence of sleep disorders.\n\nIt includes 19 questions that combine to evaluate 7 components of sleep, each evaluated from 0 to 3 (0 = no difficulty, 3 = severe difficulty).\n\nA total score greater than 5 indicates a sleep disorder.'}], 'secondaryOutcomes': [{'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '1 month from child birth', 'description': 'Online self-report questionnaire that assesses sleep quality filled at 1 month, 3 months and 6 months from child birth.'}, {'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '3 months from child birth', 'description': 'Online self-report questionnaire that assesses sleep quality filled at 1 month, 3 months and 6 months from child birth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity', 'Parenting', 'Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Couple of Parents of child born at the CHRU of Brest (full-term in maternity or premature child (25-36 weeks) hospitalized in maternity, neonatalogy or unity of intensive neonatal care).\n\nBoth Parents will be included, each of them will have to fill the PSQI at 1, 3 and 6 months from the child birth.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couple of parents of children born before term (between 25 and 36 weeks) and hospitalized at the CHRU de Brest.\n* Parents of healthy full-term children born at Brest CHRU (\\> 37 weeks) without neonatal hospitalization.\n* Having formulated their agreement\n\nExclusion Criteria:\n\n* Parents whose child died in the neonatal period.\n* Couple whose one parents are minors at the birth of the child.\n* Parents of children with malformation and /or genetic anomaly.\n* Parents with known addiction, depressive syndrome or known psychiatric condition before birth.\n* Single parent family.\n* Non-French speaking parents.\n* Refusal of participation of one of the parents.'}, 'identificationModule': {'nctId': 'NCT03693651', 'acronym': 'SLEEP-PP', 'briefTitle': 'Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity', 'orgStudyIdInfo': {'id': 'SLEEP-PP (29BRC18.0079)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parent of a Premature infant / PP', 'description': 'self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth.'}, {'label': 'Parent of a baby born on time / PT', 'description': 'self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques SIZUN', 'role': 'CONTACT', 'email': 'jacques.sizun@chu-brest.fr', 'phone': '02 98 22 36 67'}, {'name': 'Jean-Michel ROUE', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr', 'phone': '02 98 22 36 67'}, {'name': "Hortense LANGLOIS D'ESTAINTOT, Interne", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Jacques SIZUN, Pr', 'role': 'CONTACT', 'email': 'jacques.sizun@chu-brest.fr', 'phone': '02 98 22 36 67'}, {'name': 'Jean-Michel ROUE, Dr', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr', 'phone': '02 98 22 36 67'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}