Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT01143233
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2010-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2010-06-11', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average weight gain', 'timeFrame': '4 months', 'description': 'The intervention is to assess average weight gain in the first 4 months of life.'}], 'secondaryOutcomes': [{'measure': 'allergic sensitization and symptoms', 'timeFrame': '12 months', 'description': 'blood sample to assess allergic predisposition'}, {'measure': 'Anthropometric data at age of 4 years', 'timeFrame': '4 years', 'description': 'Weight, length and Head circumference measurements at Age of 4 years'}, {'measure': 'Body composition (Skin fold) at age of 4 years', 'timeFrame': '4 years', 'description': 'Caliper measurement at Age of 4 years'}, {'measure': 'Body composition (fat mass, lean body mass) at age of 4 years', 'timeFrame': '4 years', 'description': 'bioelectrical impedance Analysis at Age of 4 years'}, {'measure': 'Allergic predisposition at age of 4 years by measuring specific IgE in blood', 'timeFrame': '4 years', 'description': 'blood sample to allergic predisposition at Age of 4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Disturbance of Growth']}, 'referencesModule': {'references': [{'pmid': '29216020', 'type': 'DERIVED', 'citation': 'Ahrens B, Hellmuth C, Haiden N, Olbertz D, Hamelmann E, Vusurovic M, Fleddermann M, Roehle R, Knoll A, Koletzko B, Wahn U, Beyer K. Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):822-830. doi: 10.1097/MPG.0000000000001853.'}]}, 'descriptionModule': {'briefSummary': 'The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.\n\nPrimary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.\n\n4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.', 'detailedDescription': 'View Section Brief Summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent (by parents, caregiver)\n* Healthy term newborns (gestational age: ≥ 37 weeks)\n* Birth weight between 2.500 - 4.500 g\n* Age at enrolment: \\< 28 days of age\n* Infant received no other formula since birth\n* Parents / Caregivers are able to speak German\n\nExclusion Criteria:\n\n* Severe acquired or congenital illness\n* preterm infants (gestational age \\< 37 weeks)\n* Birth weight lower than 2.500 g or higher than 4.500 g\n* Feeding a cows milk based formula or any other formula prior to inclusion in this study\n* Participation in any other clinical study intervention\n* Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother\n* Mothers with diabetes mellitus or mothers suffered from gestational diabetes\n* Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol\n* Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child\n* Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase'}, 'identificationModule': {'nctId': 'NCT01143233', 'acronym': 'HippHA', 'briefTitle': 'Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'HiPP GmbH & Co. Vertrieb KG'}, 'officialTitle': 'Suitability of an Infant Formula With Reduced Protein Content Based on a Partial Respectively an Extensive Proteinhydrolysate With and Without Pro- and Prebiotics for the Particular Nutritional Use by Infants.-Extension by 4 Year Follow-up', 'orgStudyIdInfo': {'id': 'Hipp2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control formula group', 'description': 'infants are fed a commercial, hydrolysed formula during the first 4 month of life, according to protocol', 'interventionNames': ['Other: control formula']}, {'type': 'EXPERIMENTAL', 'label': 'intervention formula 1 group', 'description': 'infants are fed hydrolyzed infant formula with different protein content during the first 4 month of life, according to protocol', 'interventionNames': ['Other: intervention formula 1']}, {'type': 'EXPERIMENTAL', 'label': 'intervention formula 2 group', 'description': 'infants are fed hydrolyzed infant formula with different protein content with pro- and prebiotics during the first 4 month of life, according to protocol', 'interventionNames': ['Other: intervention formula 2']}, {'type': 'EXPERIMENTAL', 'label': 'intervention formula 3 group', 'description': 'infants are fed hydrolyzed instant formula with different protein content with pro- and prebiotics during the first 4 months of life, according to protocol', 'interventionNames': ['Other: intervention formula 3']}, {'type': 'NO_INTERVENTION', 'label': 'Reference group', 'description': 'infants are breast fed'}], 'interventions': [{'name': 'control formula', 'type': 'OTHER', 'description': 'infants are fed a commercial hydrolyzed formula', 'armGroupLabels': ['control formula group']}, {'name': 'intervention formula 1', 'type': 'OTHER', 'description': 'formula has hydrolysed protein and a different protein content', 'armGroupLabels': ['intervention formula 1 group']}, {'name': 'intervention formula 2', 'type': 'OTHER', 'description': 'formula has hydrolysed protein, different protein content and pro- and prebiotics', 'armGroupLabels': ['intervention formula 2 group']}, {'name': 'intervention formula 3', 'type': 'OTHER', 'description': 'formula has hydrolysed protein, different protein content and pro- and prebiotics', 'armGroupLabels': ['intervention formula 3 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinik für Kinder- und Jugendheilkunde, Abt. Neonatologie, päd. Intensivmedizin und Neuropädiatrie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '18059', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'University Hospital Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'KBC "Dr Dragiša Mišović Dedinje"', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Ulrich Wahn, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie'}, {'name': 'Kirsten Beyer, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HiPP GmbH & Co. Vertrieb KG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}