Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT03489733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-03
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Allergic Diseases in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1170}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of atopic dermatitis', 'timeFrame': '1 year', 'description': 'Presence of atopic dermatitis on physical examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Diseases']}, 'descriptionModule': {'briefSummary': 'A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '56 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth)\n* Birth weight ≥ 2500 g and ≤ 4500 g\n* Age at enrollment: ≤ 56 days of life\n* At risk of developing atopic diseases\n* Free of atopy symptoms at Screening and at any time before randomization\n* Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed\n* Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):\n\n * IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life\n * breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.\n * No other infant formulas or solid foods are allowed.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Multiple births\n* Premature delivery (gestational age ≤ 36+6)\n* Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)\n* Significant congenital abnormalities\n* Participation in another clinical study with an IP or study method that would influence the outcome of this study\n* Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements."}, 'identificationModule': {'nctId': 'NCT03489733', 'briefTitle': 'Prevention of Allergic Diseases in Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'HiPP GmbH & Co. Vertrieb KG'}, 'officialTitle': 'The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age', 'orgStudyIdInfo': {'id': '508917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Infant Formula with hydrolyzed protein and breast milk until at least 120 days of life', 'interventionNames': ['Other: Hydrolyzed Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Infant Formula with intact protein and breast milk until at least 120 days of life', 'interventionNames': ['Other: Control formula']}, {'type': 'NO_INTERVENTION', 'label': 'Breast Fed Group', 'description': 'Exclusively breast ilk until at least 120 days of life'}], 'interventions': [{'name': 'Hydrolyzed Formula', 'type': 'OTHER', 'description': 'Infant formula with extensively hydrolyzed proteins and pre- and probiotics.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Control formula', 'type': 'OTHER', 'description': 'Infant formula with intact proteins and pre- and probiotics.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Strakonice', 'country': 'Czechia', 'facility': 'Nemocnice Strakonice, a.s.', 'geoPoint': {'lat': 49.26141, 'lon': 13.90237}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Suomen Terveystalo Oy', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM)', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamm', 'country': 'Germany', 'facility': 'Klinik für Kinder und Jugendmedizin', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'city': 'Wesel', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel', 'geoPoint': {'lat': 51.6669, 'lon': 6.62037}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Unità Allergologia-Unità Allergologia-', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Instytut Mikroekologii', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Braga', 'country': 'Portugal', 'facility': 'Hospital braga', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'overallOfficials': [{'name': 'Kirsten Beyer, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HiPP GmbH & Co. Vertrieb KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}