Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT06768203
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2024-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-08', 'size': 167669, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-09T06:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The splanchnic oxygenation (rSO2S)', 'timeFrame': 'first week of life (7 days)', 'description': 'The primary outcomes included comparing continuously recorded rSO2S and FOE values during the first week of life between the UVC (+) and UVC (-) groups, assessing rSO2S and FOE measurements within the UVC (+) Group before and after UVC placement and removal, and determining the impact of UVC on splanchnic oxygenation'}], 'secondaryOutcomes': [{'measure': 'The incidence of feeding intolerance and necrotizing enterocolitis.', 'timeFrame': 'During hospital stay (maximum 3 months)', 'description': 'The secondary outcomes involve evaluating the relationship between UVC presence and the incidence of feeding intolerance and necrotizing enterocolitis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['umbilical venous catheter', 'splanchnic oxygenation', 'near-infrared spectroscopy', 'small for gestational age', 'feeding intolerance'], 'conditions': ['Feeding Intolerance', 'Necrotising Enterocolitis Neonatal']}, 'referencesModule': {'references': [{'pmid': '33504960', 'type': 'RESULT', 'citation': 'van der Heide M, Dotinga BM, Stewart RE, Kalteren WS, Hulscher JBF, Reijneveld SA, Bos AF, Kooi EMW. Regional splanchnic oxygen saturation for preterm infants in the first week after birth: reference values. Pediatr Res. 2021 Oct;90(4):882-887. doi: 10.1038/s41390-020-01323-3. Epub 2021 Jan 27.'}, {'pmid': '36637540', 'type': 'RESULT', 'citation': 'Surmeli Onay O, Velipasaoglu M, Tutal M, Sarilar TD, Cakil Saglik A, Bilgin M, Aydemir O, Barsan Kaya T, Tanir HM, Tekin AN. The effect of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction: a prospective randomized trial. Eur J Pediatr. 2023 Mar;182(3):1317-1328. doi: 10.1007/s00431-023-04810-x. Epub 2023 Jan 13.'}, {'pmid': '28092913', 'type': 'RESULT', 'citation': 'Sulemanji M, Vakili K, Zurakowski D, Tworetzky W, Fishman SJ, Kim HB. Umbilical Venous Catheter Malposition Is Associated with Necrotizing Enterocolitis in Premature Infants. Neonatology. 2017;111(4):337-343. doi: 10.1159/000451022. Epub 2017 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: This study aimed to assess the impact of umbilical vein catheter (UVC) placement on splanchnic oxygenation in preterm infants.\n\nMethods: In our single-center, prospective, observational cohort study, near-infrared spectroscopy probes were placed to monitor regional splanchnic oxygen saturation (rSO2S) and calculate fractional tissue oxygen extraction (FOE) in preterm infants (GA \\< 34 weeks, BW 1000-2000 g) for one week post-stabilization. Gestational age-matched UVC (+) and (-) Groups were clinically and physiologically compared, before and after UVC placement/removal.', 'detailedDescription': 'The purpose of this study was to evaluate how the insertion of an umbilical vein catheter (UVC) affected the splanchnic oxygenation of preterm newborns..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants whose gestational age is \\<34 weeks, birth weight 1000-2000 grams.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents agreed to participate in the study\n* Infants born in our hospital, who were followed up in the NICU, with a gestational age of \\<34 weeks and a birth weight of 1000-2000 grams\n* Infants who indicated UVC placement, and for whom NIRS measurements were taken both before and after UVC placement were included in the UVC (+) Study Group\n* Infants who did not have a UVC but matched the Study Group regarding gestational age and birth weight constituted the UVC (-) Control Group\n\nExclusion Criteria:\n\n* Infants who died during the first week of life\n* Transferred to another hospital\n* Chromosomal anomalies\n* Major congenital anomalies affecting splanchnic bed monitoring (such as congenital heart disease, abdominal wall defects, or congenital diaphragmatic hernia)\n* Inherited metabolic disorders\n* Hydrops fetalis\n* TORCH infections\n* Multiple organ failure\n* Spontaneous intestinal perforation\n* Lesions in the area where the NIRS sensor was placed\n* If UVC was removed for any reason before 24 hours\n* Severe anemia or polycythemia (Infants with a birth hemoglobin (Hb) level of 10 g/dl or below were considered severe anemic, and those with a Hb level of 22 g/dl or above were considered polycythemic)'}, 'identificationModule': {'nctId': 'NCT06768203', 'briefTitle': 'The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation', 'orgStudyIdInfo': {'id': 'EskisehirOU-UVC STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The UVC (+) Study Group', 'description': 'Infants who indicated UVC placement, and for whom NIRS measurements were taken both before and after UVC placement were included in the UVC (+) Study Group.', 'interventionNames': ['Other: umbilical vein catheterization']}, {'label': 'The UVC (-) Control Group', 'description': 'Infants who did not have a UVC but matched the Study Group regarding gestational age and birth weight constituted the UVC (-) Control Group.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'umbilical vein catheterization', 'type': 'OTHER', 'description': "In our NICU, UVC placement is a sterile bedside procedure carried out by pediatric residents, neonatology fellows, and neonatology specialists, using polyurethane, single-lumen catheters sized according to the infant's weight: 3.5 Fr for those under 1500 g and 5 Fr for those over 1500 g. Catheter placement is performed using the Modified Shukla-Ferrara Formula", 'armGroupLabels': ['The UVC (+) Study Group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No umbilical vein catheter was inserted in these infants.', 'armGroupLabels': ['The UVC (-) Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eskişehir', 'country': 'Turkey (Türkiye)', 'facility': 'Eskisehir Osmangazi University', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'overallOfficials': [{'name': 'Ozge Surmeli Onay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eskisehir Osmangazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Ozge Surmeli Onay', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}