Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-14 @ 6:55 AM
Study NCT ID:
NCT03983694
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2019-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017707', 'term': 'Erythrocyte Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral metabolic rate of oxygen index (CMRO2i)', 'timeFrame': 'From immediately before to immediately after RBC transfusion', 'description': 'The change in an index proportional to CMRO2'}], 'secondaryOutcomes': [{'measure': 'Tissue oxygen saturation (rStO2)', 'timeFrame': 'From immediately before to immediately after RBC transfusion', 'description': 'The change in oxygenated haemoglobin/total haemoglobin'}, {'measure': 'Cerebral blood flow index (CBFi)', 'timeFrame': 'From immediately before to immediately after RBC transfusion', 'description': 'The change in an index proportional to CBF'}, {'measure': 'Differential path length factor (DPF)', 'timeFrame': 'From immediately before to immediately after RBC transfusion', 'description': 'The change in an optical parameter for physiological measurement using NIRS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Haemodynamics', 'Erythrocyte Transfusion']}, 'referencesModule': {'references': [{'pmid': '24797124', 'type': 'BACKGROUND', 'citation': 'Banerjee J, Aladangady N. Biomarkers to decide red blood cell transfusion in newborn infants. Transfusion. 2014 Oct;54(10):2574-82. doi: 10.1111/trf.12670. Epub 2014 May 5.'}, {'pmid': '16292938', 'type': 'BACKGROUND', 'citation': 'Cerussi A, Van Woerkom R, Waffarn F, Tromberg B. Noninvasive monitoring of red blood cell transfusion in very low birthweight infants using diffuse optical spectroscopy. J Biomed Opt. 2005 Sep-Oct;10(5):051401. doi: 10.1117/1.2080102.'}, {'pmid': '23145971', 'type': 'BACKGROUND', 'citation': 'Koyano K, Kusaka T, Nakamura S, Nakamura M, Konishi Y, Miki T, Ueno M, Yasuda S, Okada H, Nishida T, Isobe K, Itoh S. The effect of blood transfusion on cerebral hemodynamics in preterm infants. Transfusion. 2013 Jul;53(7):1459-67. doi: 10.1111/j.1537-2995.2012.03953.x. Epub 2012 Nov 12.'}, {'pmid': '20099219', 'type': 'BACKGROUND', 'citation': 'Bailey SM, Hendricks-Munoz KD, Wells JT, Mally P. Packed red blood cell transfusion increases regional cerebral and splanchnic tissue oxygen saturation in anemic symptomatic preterm infants. Am J Perinatol. 2010 Jun;27(6):445-53. doi: 10.1055/s-0030-1247598. Epub 2010 Jan 22.'}, {'pmid': '20113454', 'type': 'BACKGROUND', 'citation': 'Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22.'}, {'pmid': '23901886', 'type': 'BACKGROUND', 'citation': 'Sandal G, Oguz SS, Erdeve O, Akar M, Uras N, Dilmen U. Assessment of red blood cell transfusion and transfusion duration on cerebral and mesenteric oxygenation using near-infrared spectroscopy in preterm infants with symptomatic anemia. Transfusion. 2014 Apr;54(4):1100-5. doi: 10.1111/trf.12359. Epub 2013 Jul 31.'}], 'seeAlsoLinks': [{'url': 'http://www.babylux-project.eu/', 'label': 'The BabyLux project web-site'}]}, 'descriptionModule': {'briefSummary': 'The timing and the indications for red blood cell (RBC) transfusions remain one of the most controversial topic in Neonatology. Indeed, biomarkers routinely used to discriminate between patients that will benefit from RBC transfusion appear insufficient. Tissue oxygenation could be useful to determine the need for transfusion.\n\nThis study aims to assess the effects of RBC transfusion on cerebral haemodynamics and oxygenation in neonates with a new hybrid optical device (BabyLux) integrating time-resolved spectroscopy (NIRS-TRS) and diffuse correlation spectroscopy (DCS).\n\nIt is hypothesized that cerebral blood flow decreases after RBC transfusion, whereas cerebral oxygenation and oxygen metabolism are unchanged.', 'detailedDescription': 'The BabyLux hybrid setup can determine the following parameters in the same tissue sample non-invasively and continuously with a high temporal resolution (0.1-0.2 Hz):\n\n* Cerebral blood flow index (CBFi), i.e. an index that is proportional with CBF\n* Concentration of oxyhaemoglobin (O2Hb)\n* Concentration of deoxyhaemoglobin (dHb)\n* Total haemoglobin concentration (tHb)\n* Tissue oxygen saturation (rStO2)\n* Cerebral metabolic rate of oxygen index (CMRO2i), i.e. an index that is proportional with CMRO2 Hence, the BabyLux device allows assessment of key parameters of cerebral haemodynamics and, in particular, to examine if the percentage change of cerebral metabolic rate for oxygen is close to the expected zero, as an external quality control of the separate NIRS parameters.\n\nThere are no studies on RBC transfusion in neonates evaluating cerebral haemodynamic utilizing DCS and TRS combined.\n\nHence, primary aim of this study is:\n\n\\- to assess the effect of RBC transfusion on cerebral haemodynamics and oxygenation as measured by the Babylux device.\n\nSecondary aims are:\n\n* to quantify the effect of estimated ∆\\[Hb\\] on the differential path length factor (DPF);\n* to compare two different NIRS devices and techniques. BabyLux measurement will be performed before and after RBC transfusion, whereas during RBC transfusion cerebral oxygenation will be monitored with a spatially resolved continuous wave (CW) NIRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '0 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn infants admitted to a neonatal intensive care unit and who need an erythrocyte transfusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RBC transfusion prescribed according to local NICU guidelines\n* Corrected age \\< 4 weeks corrected age\n* Signed informed consent\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03983694', 'briefTitle': 'Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates', 'orgStudyIdInfo': {'id': 'BabyLux transfusion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BabyLux device', 'description': 'Cerebral haemodynamics of neonates undergoing erythrocyte transfusion according to the local clinical guidelines are monitored with BabyLux device before and after transfusion and with traditional NIRS during itself.', 'interventionNames': ['Other: Erythrocyte transfusion']}], 'interventions': [{'name': 'Erythrocyte transfusion', 'type': 'OTHER', 'description': 'The cerebro-vascular effects of a clinically prescribed erytrocyte (red blood cell) transfusion is examined. Before the transfusion, BabyLux sensor is placed on the neonatal fronto-parietal region and held in place by a self-adhesive bandage. A baseline prior to transfusion is established through a series of five repeated measurements of 1 minute taken during a stable period just before the transfusion is started. Once transfusion has ended, another series of five repeated measurements of 1 minute taken during a stable period are performed to determine the responses. Cerebral oxygenation as determined by a commercial spatially resolved NIRS device with neonatal sensor will be continuously recorded during transfusion.', 'armGroupLabels': ['BabyLux device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gorm Greisen', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Gorm Greisen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}