Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-04-24 @ 4:47 AM
Study NCT ID:
NCT02722759
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2016-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haemoglobin Measurement for Babies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of different methods (SpHb, HcHb,BGAHb) of haemoglobin measurement compared with the gold standard labHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'accuracy is assessed by Bland-Altman-method of comparison, by Root mean square error and by out of range'}], 'secondaryOutcomes': [{'measure': 'handling of the SpHb-device', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'measurement of how often the Radical-7 has to be replaced and of the time until a stable Signal appears'}, {'measure': 'influence of weight and gender on accuracy of SpHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of PI with the accuracy of SpHb'}, {'measure': 'influence of PI (perfusion index) on accuracy of SpHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of PI with the accuracy of SpHb'}, {'measure': 'influence of concentration of HbF on accuracy of SpHb,BGAHb, HcHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of concentration of HbF with the accuracy of SpHb'}, {'measure': 'influence of concentration of Hb on accuracy of SpHb,BGAHb, HcHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of concentration of Hb with the accuracy of SpHb'}, {'measure': 'agreement of concentration of HbF of BGAHb with HbF of labHb', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'accuracy is assessed by Bland-Altman-method of comparison'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemoglobins', 'Infant', 'Non-invasive']}, 'referencesModule': {'references': [{'pmid': '30427065', 'type': 'BACKGROUND', 'citation': 'Wittenmeier E, Lesmeister L, Pirlich N, Dette F, Schmidtmann I, Mildenberger E. Assessment of haemoglobin measurement by several methods - blood gas analyser, capillary and venous HemoCue(R) , non-invasive spectrophotometry and laboratory assay - in term and preterm infants. Anaesthesia. 2019 Feb;74(2):197-202. doi: 10.1111/anae.14481. Epub 2018 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective study different methods of haemoglobin measurement in term and preterm neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@, Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin measurement by an automated hematology analyzer (labHb, Siemens Advia®).', 'detailedDescription': 'Neonates admitted to neonatal intensive care unit or to a normal neonatal ward are enrolled in the study, if parents have given their written informed consent. Non-invasive SpHb measurements are recorded prior to routine venous sampling. Routine venous sampling includes labHb and BGAHb. Additionally HcHb is taken from the routine venous sampling (HcHbart/ven) and from an additionally capillary puncture of earlobe or heel (HcHbcap). Every neonate can participate in two measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'gender both\n\nage limits minimum age 3 days of life maximum age 44 postmenstrual weeks\n\naccepts no healthy volunteers\n\nInclusion Criteria:\n\nwritten informed consent of the parents\n\n\\-\n\nExclusion Criteria:\n\n* allergy against sensor patch\n* medical or psychological factors that inhibit a correct finazilation of the study'}, 'identificationModule': {'nctId': 'NCT02722759', 'briefTitle': 'Haemoglobin Measurement for Babies', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Comparison of Alternative Non-invasive and Invasive Methods of Haemoglobin Measuring With the Gold Standard in Preterm and Term Neonates', 'orgStudyIdInfo': {'id': 'Haemoglobin2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'hemoglobin measurement arm', 'description': 'In this arm hemoglobin measurement is done by four different devices\n\n* device "Radical-7" for non-invasive measurement of SpHb\n* device "HemoCue" for taking capillary and venous blood for measurement of HcHb\n* device "ABL 800" for measurement of BGAHb\n* device "Siemens ADVIA" for measurement of labHb\n\nFor measurement of haemoglobin by the devices the following interventions have to be done:\n\n* venous or arterial puncture (routine)\n* capillary puncture\n* placing of the "Radical 7" sensor', 'interventionNames': ['Other: hemoglobin measurement']}], 'interventions': [{'name': 'hemoglobin measurement', 'type': 'OTHER', 'armGroupLabels': ['hemoglobin measurement arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Dr. Eva Wittenmeier', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Eva Wittenmeier:MD', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}