Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-13 @ 11:15 PM
Study NCT ID:
NCT03643458
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-transfusion splanchnic oxygenation pattern', 'timeFrame': 'Enteral feed before red blood cell transfusion administration (3 hours)', 'description': 'Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value'}, {'measure': 'Post-transfusion splanchnic oxygenation pattern', 'timeFrame': 'Enteral feed after red blood cell transfusion administration (3 hours)', 'description': 'Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value'}], 'secondaryOutcomes': [{'measure': 'Incidence of gut complications', 'timeFrame': '48 hours after transfusion', 'description': 'Occurrence of necrotizing enterocolitis or feeding intolerance in infants undergone red blood cell transfusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NIRS', 'TANEC', 'splanchnic oxygenation', 'enteral feeding', 'preterm infants'], 'conditions': ['Blood Transfusion Complication', 'Necrotizing Enterocolitis', 'Enteral Feeding Intolerance', 'Preterm Infant']}, 'referencesModule': {'references': [{'pmid': '23480548', 'type': 'BACKGROUND', 'citation': 'Marin T, Moore J, Kosmetatos N, Roback JD, Weiss P, Higgins M, McCauley L, Strickland OL, Josephson CD. Red blood cell transfusion-related necrotizing enterocolitis in very-low-birthweight infants: a near-infrared spectroscopy investigation. Transfusion. 2013 Nov;53(11):2650-8. doi: 10.1111/trf.12158. Epub 2013 Mar 11.'}, {'pmid': '26410441', 'type': 'BACKGROUND', 'citation': 'White L, Said M, Rais-Bahrami K. Monitoring mesenteric tissue oxygenation with near-infrared spectroscopy during packed red blood cell transfusion in preterm infants. J Neonatal Perinatal Med. 2015;8(2):157-63. doi: 10.3233/NPM-15814090.'}, {'pmid': '25761320', 'type': 'BACKGROUND', 'citation': 'Bailey SM, Hendricks-Munoz KD, Mally PV. Variability in splanchnic tissue oxygenation during preterm red blood cell transfusion given for symptomatic anaemia may reveal a potential mechanism of transfusion-related acute gut injury. Blood Transfus. 2015 Jul;13(3):429-34. doi: 10.2450/2015.0212-14. Epub 2015 Jan 30.'}, {'pmid': '24948351', 'type': 'BACKGROUND', 'citation': 'Marin T, Josephson CD, Kosmetatos N, Higgins M, Moore JE. Feeding preterm infants during red blood cell transfusion is associated with a decline in postprandial mesenteric oxygenation. J Pediatr. 2014 Sep;165(3):464-71.e1. doi: 10.1016/j.jpeds.2014.05.009. Epub 2014 Jun 16.'}, {'pmid': '19021097', 'type': 'BACKGROUND', 'citation': 'Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.'}, {'pmid': '26643925', 'type': 'BACKGROUND', 'citation': 'Banerjee J, Leung TS, Aladangady N. Effect of blood transfusion on intestinal blood flow and oxygenation in extremely preterm infants during first week of life. Transfusion. 2016 Apr;56(4):808-15. doi: 10.1111/trf.13434. Epub 2015 Dec 8.'}, {'pmid': '27509230', 'type': 'BACKGROUND', 'citation': 'Banerjee J, Leung TS, Aladangady N. Blood transfusion in preterm infants improves intestinal tissue oxygenation without alteration in blood flow. Vox Sang. 2016 Nov;111(4):399-408. doi: 10.1111/vox.12436. Epub 2016 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.\n\nEvidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion; a possible role for these findings in increasing the risk for TANEC development has been hypothesized.\n\nThe aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.', 'detailedDescription': 'Premature neonates are among the most transfused population, but the risks and benefits of this procedure remain unclear. Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most common and feared gastrointestinal complications of prematurity. Several observational studies have tried to demonstrate this causal correlation, defining the so-called transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.\n\nEvidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion. This evidence, which has been hypothesized to play a role on the risk of TANEC development, has significantly raised the attention over the feeding plans during and after RBC transfusion.\n\nTo date, splanchnic oxygenation response to feeds before and after transfusion has not been investigated, but could bring useful information to understand the splanchnic hemodynamic changes associated to RBC transfusion.\n\nTherefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.\n\nEnrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2) oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal sensors will be placed in the central region of the forehead and the below the umbilicus, respectively.\n\nThe study monitoring includes the following phases:\n\n* Phase 1 (0-3 hours): pre-transfusion feed and related post-prandial period\n* Phase 2 (4-9 hours): RBC transfusion (10 ml/kg),administered over 3 hours, following which feeds are hold for 3 hours.\n* Phase 3 (10-12 hours): post-transfusion feed and related post-prandial period.\n\nCrSO2 and SrSO2 patterns before and after transfusion and the related changes from baseline values will be analyzed. SCOR (CrSO2/SrSO2 ratio) patterns will be also calculated and analyzed. IBM SPSS Statistics (Statistical Package for the Social Sciences, SPSS Inc., IBM, Armonk, NY) will be used for statistical analysis. If any infant develops TANEC after transfusion, the related patterns will be evaluated and analyzed separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anemic preterm infants requiring red blood cell transfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age \\<32 weeks or birth weight \\<1500 g\n* need for red blood cell transfusion according to national guidelines\n\nExclusion Criteria:\n\n* hemodynamic instability\n* Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion'}, 'identificationModule': {'nctId': 'NCT03643458', 'acronym': 'NIRS_RBC', 'briefTitle': 'Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants', 'orgStudyIdInfo': {'id': 'SO-2014-NIRS'}, 'secondaryIdInfos': [{'id': '122/2012/U/Oss', 'type': 'OTHER', 'domain': 'Ethic Committee of St.Orsola-Malpighi University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transfused infants', 'description': 'Preterm infants undergone red blood cell transfusion during hospital stay.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Luigi Corvaglia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.Orsola-Malpighi University Hospital, Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Luigi Corvaglia', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}