Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 1:35 PM
Study NCT ID:
NCT04819893
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012164', 'term': 'Retinal Diseases'}], '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': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017218', 'term': 'Cordocentesis'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery', 'timeFrame': '16 weeks maximum after birth'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity', 'Retinopathy']}, 'referencesModule': {'references': [{'pmid': '37803473', 'type': 'DERIVED', 'citation': 'Carre C, Acar N, Daruich A, Gregoire S, Martine L, Buteau B, Aho S, Eid P, Arnould L, Bron AM, Driessen M, Kermorvant E, Simon E, Creuzot-Garcher C, Gabrielle PH. Study protocol of OmegaROP-2 prospective study: expression of placental fatty acid receptors in preterm newborns with retinopathy of prematurity. BMC Ophthalmol. 2023 Oct 6;23(1):404. doi: 10.1186/s12886-023-03156-0.'}]}, 'descriptionModule': {'briefSummary': 'The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women giving birth at term or prematurely', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.\n2. Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.\n3. ≥18 years\n4. Mothers not under legal protection\n\nExclusion Criteria:\n\n1. Mothers giving birth between 29WA and 38WA+6 days\n2. Mothers in critical condition.\n3. Person not affiliated to national health insurance\n4. For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).'}, 'identificationModule': {'nctId': 'NCT04819893', 'acronym': 'OMEGAROP 2', 'briefTitle': 'Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.', 'orgStudyIdInfo': {'id': 'CREUZOT-GARCHER 2020-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women giving birth prematurely', 'description': 'Delivery before 29 WA', 'interventionNames': ['Biological: Maternal blood sampling', 'Biological: Umbilical cord blood sampling', 'Biological: Placenta sampling', 'Other: Data collection']}, {'label': 'Women giving birth at term', 'description': 'Childbirth between 39WA and 31WA+6 days', 'interventionNames': ['Biological: Maternal blood sampling', 'Biological: Umbilical cord blood sampling', 'Biological: Placenta sampling']}], 'interventions': [{'name': 'Maternal blood sampling', 'type': 'BIOLOGICAL', 'description': '5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols', 'armGroupLabels': ['Women giving birth at term', 'Women giving birth prematurely']}, {'name': 'Umbilical cord blood sampling', 'type': 'BIOLOGICAL', 'description': '0.5mL sample from the umbilical cord after childbirth standard protocols', 'armGroupLabels': ['Women giving birth at term', 'Women giving birth prematurely']}, {'name': 'Placenta sampling', 'type': 'BIOLOGICAL', 'description': 'Sampling of 3 cotyledons by cutting across the thickness of the placenta', 'armGroupLabels': ['Women giving birth at term', 'Women giving birth prematurely']}, {'name': 'Data collection', 'type': 'OTHER', 'description': 'Newborn, Maternal and Premature Retinopathy Screening Data Collection', 'armGroupLabels': ['Women giving birth prematurely']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chloé Carré', 'role': 'CONTACT', 'email': 'ccarre34@gmail.com'}], 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Catherine CREUZOT-GARCHER', 'role': 'CONTACT', 'email': 'catherine.creuzot-garcher@chu-dijon.fr', 'phone': '03.80.29.51.73'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}