Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-20 @ 6:13 PM
Study NCT ID:
NCT03662503
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': '36 weeks', 'description': 'weight in kilograms will be evaluate between birth and age (36 adjusted age SA)'}, {'measure': 'height', 'timeFrame': '36 weeks', 'description': 'height in centimeters will be evaluate between birth and age (36 adjusted age SA)'}, {'measure': 'head circumference', 'timeFrame': '36 weeks', 'description': 'head circumference in centimeters will be evaluate between birth and age (36 adjusted age SA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child\'s health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.\n\nThe optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.\n\nThe optimization of nutrition in premature children is therefore a topical issue in neonatology.\n\nOur project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.\n\nNutritional intake during the first week of life will be analyzed in tertile. Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).\n\nThe primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".\n\nThe benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.', 'detailedDescription': 'The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child\'s health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.\n\nThe optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.\n\nThe optimization of nutrition in premature children is therefore a topical issue in neonatology.\n\nOur project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.\n\nNutritional intake (calorie intake and total protein intake) during the first week of life will be analyzed in tertile.\n\nChildren will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).\n\nThe primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".\n\nThe benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days and included in the cohort EPIPAGE 2', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children born prematurely between 30 WA (week of amenorrhea) and 32 WA + 6 days\n* Included in the cohort EPIPAGE 2 with more than 4500 inclusions. The data Perinatal, neonatal and neuro-cognitive outcome at 2 years are available.\n* This will include 2,000 children meeting these criteria.\n\nExclusion Criteria:\n\n* Children with chromosomal abnormalities or malformations congenital\n* Children who died during the neonatal period'}, 'identificationModule': {'nctId': 'NCT03662503', 'acronym': 'EPIPAGE2', 'briefTitle': 'Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature: Cohort EPIPAGE 2', 'orgStudyIdInfo': {'id': '2018-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nutrition not aggressive group', 'description': 'Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive ")'}, {'label': 'aggressive nutrition group', 'description': 'Children will be grouped according to their calorie and protein during the first week of life. the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'PACA', 'country': 'France', 'contacts': [{'name': 'ISABELLE GRANDVUILLEMIN, MD', 'role': 'CONTACT', 'email': 'Isabelle.GRANDVUILLEMIN@ap-hm.fr', 'phone': '+33 491373 432'}], 'facility': 'Assistance Publique Des Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'ISABELLE GRANDVUILLEMIN, MD', 'role': 'CONTACT', 'email': 'Isabelle.GRANDVUILLEMIN@ap-hm.fr', 'phone': '+33 491373 432'}], 'overallOfficials': [{'name': 'EMILIE GARRIDO PRADALIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}