Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT03111927
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infant Nutrition and Brain Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind - Infant Formula arms are blinded;\n\n* Reference Arm - unblinded epidemiological reference arm\n* Allocation: Randomized for formula arms, efficacy study'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants.\n\n3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain structural connectivity', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \\[Physiological marker, MRI\\].'}, {'measure': 'Brain functional connectivity', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \\[Physiological marker, MRI\\].'}, {'measure': 'Brain De novo myelination', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) \\[Physiological marker, MRI\\].'}, {'measure': 'Infant Cognitive Development', 'timeFrame': '6, 12, and 24 months of life', 'description': 'Standardized neurodevelopment test.'}, {'measure': 'Infant Early Learning Assessment', 'timeFrame': '18 and 24 months of life', 'description': 'Computer-based cognitive tasks.'}, {'measure': 'Infant Social Emotional Development', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'Parent report questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Infant dietary assessment', 'timeFrame': '6, 9, 12, 18, and 24 months of life', 'description': 'Three days food records are planned at the specified time-frames.'}, {'measure': 'Breast milk nutrients profile', 'timeFrame': 'week 3, week 6, and 3 months of life', 'description': 'Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) \\[Physiological parameter\\].'}, {'measure': 'Brain structure', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'MRI'}, {'measure': 'Blood nutrients profile (optional)', 'timeFrame': '6, 12, and 24 months of life', 'description': 'Nutrients (vitamins, minerals, and other nutrients) levels'}, {'measure': 'Sleep', 'timeFrame': '3, 6, 12, 18, and 24 months of life', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition, Brain Development, Cognition, Heathy Infants'], 'conditions': ['Healthy', 'Infant Development']}, 'referencesModule': {'references': [{'pmid': '35242798', 'type': 'DERIVED', 'citation': "Schneider N, Bruchhage MMK, O'Neill BV, Hartweg M, Tanguy J, Steiner P, Mutungi G, O'Regan J, Mcsweeney S, D'Sa V, Deoni SCL. A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial. Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 2022."}]}, 'descriptionModule': {'briefSummary': 'Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.', 'detailedDescription': "This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.\n\nOnce all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.\n\nProduct codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '2 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term infants (≥ 37 weeks)\n* Neuro typical development\n* No major risk factors for learning, neurologic, or psychiatric disorder\n* Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.\n* Parents/legal guardians willing and able to complete the informed consent process\n\nExclusion Criteria:\n\n* Delayed birth (\\> 41 weeks gestation)\n* Birth Weight \\< 2000 g or small for gestation age or large for gestational age\n* Psychopharmacological treatment of mother using prohibited medications during pregnancy\n* In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists\n* Abnormalities on fetal ultrasound\n* Complicated pregnancy\n* Neonatal intensive care unit admission and/or emergency surgical delivery'}, 'identificationModule': {'nctId': 'NCT03111927', 'briefTitle': 'Infant Nutrition and Brain Development', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development', 'orgStudyIdInfo': {'id': '16.14.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Reference Arm: Breastfed', 'description': 'Epidemiological reference group of breastfed infants.'}, {'type': 'EXPERIMENTAL', 'label': 'Investigational', 'description': 'Infant Formula: enriched level of myelin-relevant nutrients', 'interventionNames': ['Other: Infant Formula: enriched level of myelin-relevant nutrients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Infant formula: standard level of myelin-relevant nutrients', 'interventionNames': ['Other: Infant formula: standard level of myelin-relevant nutrients']}], 'interventions': [{'name': 'Infant Formula: enriched level of myelin-relevant nutrients', 'type': 'OTHER', 'otherNames': ['Infant Formula'], 'description': 'Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).\n\nThe volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.', 'armGroupLabels': ['Investigational']}, {'name': 'Infant formula: standard level of myelin-relevant nutrients', 'type': 'OTHER', 'otherNames': ['Infant Formula'], 'description': 'Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).\n\nThe volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Sean Deoni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}, {'name': "Viren D'Sa, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rhode Island Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'MRI scans will be shared between sites. No Personal Identifiable Information will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}