Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-10 @ 4:18 PM
Study NCT ID:
NCT02184650
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2014-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition and Neurological Development of Very Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007228', 'term': 'Infant Nutrition Disorders'}], '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': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'saliva, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological development', 'timeFrame': 'At 3 years of age', 'description': 'Age and Stages Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature infants', 'Nutritional status', 'Polyunsaturated fatty acids status'], 'conditions': ['Premature Infant', 'Infant Nutrition Disorders', 'Delayed Mental Development']}, 'referencesModule': {'references': [{'pmid': '33910920', 'type': 'RESULT', 'citation': 'Pierrat V, Marchand-Martin L, Marret S, Arnaud C, Benhammou V, Cambonie G, Debillon T, Dufourg MN, Gire C, Goffinet F, Kaminski M, Lapillonne A, Morgan AS, Roze JC, Twilhaar S, Charles MA, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study. BMJ. 2021 Apr 28;373:n741. doi: 10.1136/bmj.n741.'}]}, 'descriptionModule': {'briefSummary': "The main goal of this study is to determine, in preterm infants born with a GA \\< 32 weeks, the association between:\n\n* the quantity of mother's milk and duration and breastfeeding\n* the intake of polyunsaturated fatty acids and iron during hospitalizations", 'detailedDescription': 'The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA \\< 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.\n\nIn the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI\\_3 is the follow-up of EPINUTRI until the age of 3 years.\n\nThe aim of EPINUTRI\\_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA \\< 32 weeks.\n\nThe secondary objective is :\n\n\\- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature infants previously included in EPINUTRI study\n* Non opposition of the parents for the collection of clinical and nutritional data\n\nExclusion Criteria:\n\n* Refusal of the parents to collect clinical and nutritional data'}, 'identificationModule': {'nctId': 'NCT02184650', 'acronym': 'EPINUTRI_3', 'briefTitle': 'Nutrition and Neurological Development of Very Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Early Nutrition and Neurological Development of Very Preterm Infants', 'orgStudyIdInfo': {'id': 'NI 13016'}, 'secondaryIdInfos': [{'id': 'ID RCB 2014-A00941-46', 'type': 'OTHER', 'domain': 'France: Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premature infants', 'description': 'Premature infants with a GA \\< 32 weeks', 'interventionNames': ['Other: Premature infants with a GA < 32 weeks']}], 'interventions': [{'name': 'Premature infants with a GA < 32 weeks', 'type': 'OTHER', 'description': 'At 3 years of age: ASQ (filled in by parents)', 'armGroupLabels': ['Premature infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Assistance Publique- Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alexandre Lapillonne, M.D, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Necker Assistance Publique-Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}