Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-26 @ 5:20 PM
Study NCT ID:
NCT03532633
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2018-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D000071700', 'term': 'Cone-Rod Dystrophies'}], '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': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of purine and pyrimidine in cord plasma', 'timeFrame': 'at birth'}], 'secondaryOutcomes': [{'measure': 'Concentration of purine and pyrimidine in neonatal plasma', 'timeFrame': 'at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)'}, {'measure': 'Concentration of purine and pyrimidine in breast milk', 'timeFrame': 'once a week before discharge home from the initial neonatal hospitalization, maximum 8 weeks'}, {'measure': 'Concentration of purine and pyrimidine in plasma of mothers', 'timeFrame': '24 hours before and after birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant', 'cord', 'micronutrients', 'purine', 'pyrimidine'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': 'Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied', 'detailedDescription': 'Collection of:\n\n1. cord plasma in preterm and term infants.\n2. remnants of clinically indicated blood samples of mothers 24 hours before or after birth.\n3. remnants of clinically indicated blood samples of preterm and term infants during neonatal care.\n4. breast milk once a weak during neonatal care of the infant.\n\nDetermination concentrations of micronutrients by mass spectrometry.\n\nAim is to compare cord plasma concentrations with postnatal plasma concentrations and to measure concentrations in breast milk to determine the actual supply.\n\nUpdate September 2020:\n\nThe results obtained according to the original protocol revealed a serious sample instability when using remnants of clinical blood samples. Remnants can not be used and therefore the protocol had to be changed. A new approval of the Ethics Committee was obtained and is available to the study team. The following changes for sample collection were implemented: an additional blood sample (2.7ml EDTA blood) is taken from the mothers after approval.The blood samples of premature and newborns (max. 3x 0.2 ml) are obtained when a clinically indicated blood sample is taken. In both cases the serum is frozen immediately within one hour after collection.\n\nDue to these changes, the expected end of the study is postponed to 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '0 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'infants and preterm infants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 23+0-42+6 SSW\n\nExclusion Criteria:\n\n* congenital malformation, genetic disorders\n* metabolic disease of the infant\n* missing agreement'}, 'identificationModule': {'nctId': 'NCT03532633', 'briefTitle': 'Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Beobachtungsstudie Zur Versorgung Reif- Und Frühgeborener Mit ausgewählten Mikronährstoffen Wissenschaftliche Untersuchung Bei Minderjährigen', 'orgStudyIdInfo': {'id': 'NEO-MICRO'}}, 'armsInterventionsModule': {'armGroups': [{'label': '23-27w', 'description': 'preterm infants 23+0-27+6SSW', 'interventionNames': ['Procedure: cord blood', 'Procedure: blood sample infant', 'Procedure: blood sample mother', 'Procedure: breast milk']}, {'label': '28-31w', 'description': 'preterm infants 28+0-31+6SSW', 'interventionNames': ['Procedure: cord blood', 'Procedure: blood sample infant', 'Procedure: blood sample mother', 'Procedure: breast milk']}, {'label': '32-34w', 'description': 'preterm infants 32+0 - 34+6SSW', 'interventionNames': ['Procedure: cord blood', 'Procedure: blood sample infant', 'Procedure: blood sample mother', 'Procedure: breast milk']}, {'label': '35-36w', 'description': 'preterm infants 35+0-36+6 SSW', 'interventionNames': ['Procedure: cord blood', 'Procedure: blood sample infant', 'Procedure: blood sample mother', 'Procedure: breast milk']}, {'label': '37-42w', 'description': 'term infants 37+0-42+6', 'interventionNames': ['Procedure: cord blood', 'Procedure: blood sample infant', 'Procedure: blood sample mother', 'Procedure: breast milk']}], 'interventions': [{'name': 'cord blood', 'type': 'PROCEDURE', 'description': 'collection of cord blood', 'armGroupLabels': ['23-27w', '28-31w', '32-34w', '35-36w', '37-42w']}, {'name': 'blood sample infant', 'type': 'PROCEDURE', 'description': 'collection of remnant of clinically indicated blood sample', 'armGroupLabels': ['23-27w', '28-31w', '32-34w', '35-36w', '37-42w']}, {'name': 'blood sample mother', 'type': 'PROCEDURE', 'description': 'collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed', 'armGroupLabels': ['23-27w', '28-31w', '32-34w', '35-36w', '37-42w']}, {'name': 'breast milk', 'type': 'PROCEDURE', 'description': 'collection of breast milk 1/week during neonatal care (maximum 8 weaks)', 'armGroupLabels': ['23-27w', '28-31w', '32-34w', '35-36w', '37-42w']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Franz, MD', 'role': 'CONTACT', 'email': 'axel.franz@med.uni-tuebingen.de', 'phone': '+497071290'}, {'name': 'Axel Franz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "University Children's Hospital Tuebingen", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Katrin Böckmann', 'role': 'CONTACT', 'email': 'katrin.a.boeckmann@gmail.com', 'phone': '+49707129', 'phoneExt': '82621'}, {'name': 'Axel Franz', 'role': 'CONTACT', 'email': 'axel.franz@med.uni-tuebingen.de', 'phone': '+49707129', 'phoneExt': '83791'}], 'overallOfficials': [{'name': 'Axel Franz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}