Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT07109856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], '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': 'D018805', 'term': 'Sepsis'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in Cerebral Fractional Tissue Oxygen Extraction (cFTOE) Between Neonates With and Without Elevated CRP', 'timeFrame': 'FTOE within 6 hours after birth; CRP within 48 hours', 'description': 'Assess whether there are significant differences in cerebral fractional tissue oxygen extraction (cFTOE) values, derived from near-infrared spectroscopy (NIRS), within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: Unitless ratio'}, {'measure': 'Difference in Peripheral Muscle Fractional Tissue Oxygen Extraction (pFTOE) Between Neonates With and Without Elevated CRP', 'timeFrame': 'FTOE within 6 hours after birth; CRP within 48 hours', 'description': 'Assess whether there are significant differences in peripheral muscle fractional tissue oxygen extraction (pFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: Unitless ratio'}, {'measure': 'Difference in Intestinal Fractional Tissue Oxygen Extraction (sFTOE) Between Neonates With and Without Elevated CRP', 'timeFrame': 'FTOE within 6 hours after birth; CRP within 48 hours', 'description': 'Assess whether there are significant differences in intestinal fractional tissue oxygen extraction (sFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: Unitless ratio'}, {'measure': 'Difference in Flank Fractional Tissue Oxygen Extraction (rFTOE) Between Neonates With and Without Elevated CRP', 'timeFrame': 'FTOE within 6 hours after birth; CRP within 48 hours', 'description': 'Assess whether there are significant differences in flank fractional tissue oxygen extraction (rFTOE) values, derived from NIRS, within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: Unitless ratio'}], 'primaryOutcomes': [{'measure': 'Optimal Cut-Off Value of the POP-Score to Predict Elevated CRP (≥ 20 mg/L)', 'timeFrame': 'Within the first 6 hours after birth (parameters of the POP-Score) and CRP within 48 hours', 'description': 'Determine the optimal cut-off value of the non-invasive POP-Score (unitless score), measured within the first 6 hours after birth, to predict elevated C-reactive protein (CRP) levels (≥ 20 mg/L) within the first 48 hours after birth in neonates with respiratory distress.'}], 'secondaryOutcomes': [{'measure': 'Difference in Peripheral Muscle Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP', 'timeFrame': 'NIRS within 6 hours after birth; CRP within 48 hours', 'description': 'Evaluate whether there are significant differences in peripheral muscle tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: % tissue oxygen saturation'}, {'measure': 'Difference in Cerebral Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP', 'timeFrame': 'NIRS within 6 hours after birth; CRP within 48 hours', 'description': 'Evaluate whether there are significant differences in cerebral tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: % tissue oxygen saturation'}, {'measure': 'Difference in Intestinal Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP', 'timeFrame': 'NIRS within 6 hours after birth; CRP within 48 hours', 'description': 'Evaluate whether there are significant differences in intestinal tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: % tissue oxygen saturation'}, {'measure': 'Difference in Flank Tissue Oxygenation by NIRS Between Neonates With and Without Elevated CRP', 'timeFrame': 'NIRS within 6 hours after birth; CRP within 48 hours', 'description': 'Evaluate whether there are significant differences in flank tissue oxygenation values measured via near-infrared spectroscopy (NIRS) within the first 6 hours after birth between neonates with elevated CRP levels (≥ 20 mg/L) and those with CRP \\< 20 mg/L.\n\nUnit of Measure: % tissue oxygen saturation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NIRS', 'near-infrared spectroscopy', 'POP-Score', 'neonates', 'preterm neonates'], 'conditions': ['Prematurity, Infections', 'NIRS', 'Near Infrared Spectroscopy', 'Preterm Neonates', 'Term Infant', 'Infection', 'Neonatal Sepsis, Early-Onset']}, 'referencesModule': {'references': [{'pmid': '22294473', 'type': 'BACKGROUND', 'citation': 'Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Zotter H, Muller W, Urlesberger B. C reactive protein: impact on peripheral tissue oxygenation and perfusion in neonates. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F444-8. doi: 10.1136/archdischild-2011-300578. Epub 2012 Jan 31.'}, {'pmid': '19775036', 'type': 'BACKGROUND', 'citation': 'Nanas S, Gerovasili V, Renieris P, Angelopoulos E, Poriazi M, Kritikos K, Siafaka A, Baraboutis I, Zervakis D, Markaki V, Routsi C, Roussos C. Non-invasive assessment of the microcirculation in critically ill patients. Anaesth Intensive Care. 2009 Sep;37(5):733-9. doi: 10.1177/0310057X0903700516.'}, {'pmid': '12507961', 'type': 'BACKGROUND', 'citation': 'Chiesa C, Pellegrini G, Panero A, Osborn JF, Signore F, Assumma M, Pacifico L. C-reactive protein, interleukin-6, and procalcitonin in the immediate postnatal period: influence of illness severity, risk status, antenatal and perinatal complications, and infection. Clin Chem. 2003 Jan;49(1):60-8. doi: 10.1373/49.1.60.'}, {'pmid': '29450194', 'type': 'BACKGROUND', 'citation': 'Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.'}, {'pmid': '19240298', 'type': 'BACKGROUND', 'citation': 'Grossauer K, Pichler G, Schmolzer G, Zotter H, Mueller W, Urlesberger B. Comparison of peripheral and cerebral tissue oxygenation index in neonates. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F156. doi: 10.1136/adc.2008.146654. No abstract available.'}, {'pmid': '17185431', 'type': 'BACKGROUND', 'citation': 'Pichler G, Grossauer K, Klaritsch P, Kutschera J, Zotter H, Muller W, Urlesberger B. Peripheral oxygenation in term neonates. Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F51-2. doi: 10.1136/adc.2005.089037.'}, {'pmid': '21654025', 'type': 'BACKGROUND', 'citation': "Pichler G, Pocivalnik M, Riedl R, Pichler-Stachl E, Morris N, Zotter H, Muller W, Urlesberger B. 'Multi-associations': predisposed to misinterpretation of peripheral tissue oxygenation and circulation in neonates. Physiol Meas. 2011 Aug;32(8):1025-34. doi: 10.1088/0967-3334/32/8/003. Epub 2011 Jun 7."}, {'pmid': '18784432', 'type': 'BACKGROUND', 'citation': "Pichler G, Wolf M, Roll C, Weindling MA, Greisen G, Wardle SP, Zaramella P, Naulaers G, Pellicer A, Austin T, Bartocci M, Urlesberger B. Recommendations to increase the validity and comparability of peripheral measurements by near infrared spectroscopy in neonates. 'Round table', section of haematology, oxygen transport and microcirculation, 48th annual meeting of ESPR, Prague 2007. Neonatology. 2008;94(4):320-2. doi: 10.1159/000151655. Epub 2008 Sep 11."}, {'pmid': '26338668', 'type': 'BACKGROUND', 'citation': 'Holler N, Urlesberger B, Mileder L, Baik N, Schwaberger B, Pichler G. Peripheral Muscle Near-Infrared Spectroscopy in Neonates: Ready for Clinical Use? A Systematic Qualitative Review of the Literature. Neonatology. 2015;108(4):233-45. doi: 10.1159/000433515. Epub 2015 Aug 25.'}, {'pmid': '39115093', 'type': 'BACKGROUND', 'citation': 'Wolfsberger CH, Hoeller N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder LP, Avian A, Schlatzer C, Urlesberger B, Pichler G. Reference ranges of peripheral-muscle oxygenation in term neonates delivered by Caesarean section during immediate transition after birth. Acta Paediatr. 2024 Dec;113(12):2582-2589. doi: 10.1111/apa.17376. Epub 2024 Aug 8.'}, {'pmid': '38034828', 'type': 'BACKGROUND', 'citation': 'Wolfsberger CH, Holler N, Baik-Schneditz N, Schwaberger B, Suppan E, Mileder L, Avian A, Urlesberger B, Pichler G. Peripheral muscle fractional tissue oxygen extraction in stable term and preterm neonates during the first 24 h after birth. Front Pediatr. 2023 Nov 15;11:1276769. doi: 10.3389/fped.2023.1276769. eCollection 2023.'}, {'pmid': '23972642', 'type': 'BACKGROUND', 'citation': 'Pichler G, Binder C, Avian A, Beckenbach E, Schmolzer GM, Urlesberger B. Reference ranges for regional cerebral tissue oxygen saturation and fractional oxygen extraction in neonates during immediate transition after birth. J Pediatr. 2013 Dec;163(6):1558-63. doi: 10.1016/j.jpeds.2013.07.007. Epub 2013 Aug 22.'}, {'pmid': '12390989', 'type': 'BACKGROUND', 'citation': 'Naulaers G, Morren G, Van Huffel S, Casaer P, Devlieger H. Cerebral tissue oxygenation index in very premature infants. Arch Dis Child Fetal Neonatal Ed. 2002 Nov;87(3):F189-92. doi: 10.1136/fn.87.3.f189.'}, {'pmid': '23873114', 'type': 'BACKGROUND', 'citation': 'Bailey SM, Hendricks-Munoz KD, Mally P. Cerebral, renal, and splanchnic tissue oxygen saturation values in healthy term newborns. Am J Perinatol. 2014 Apr;31(4):339-44. doi: 10.1055/s-0033-1349894. Epub 2013 Jul 19.'}, {'pmid': '26389823', 'type': 'BACKGROUND', 'citation': 'Alderliesten T, Dix L, Baerts W, Caicedo A, van Huffel S, Naulaers G, Groenendaal F, van Bel F, Lemmers P. Reference values of regional cerebral oxygen saturation during the first 3 days of life in preterm neonates. Pediatr Res. 2016 Jan;79(1-1):55-64. doi: 10.1038/pr.2015.186. Epub 2015 Sep 21.'}, {'pmid': '32498045', 'type': 'BACKGROUND', 'citation': 'Wolfsberger C, Baik-Schneditz N, Schwaberger B, Binder-Heschl C, Nina H, Mileder L, Bruckner M, Avian A, Urlesberger B, Pichler G. Changes in peripheral muscle oxygenation measured with near-infrared spectroscopy in preterm neonates within the first 24 h after birth. Physiol Meas. 2020 Aug 11;41(7):075003. doi: 10.1088/1361-6579/ab998b.'}, {'pmid': '36081622', 'type': 'BACKGROUND', 'citation': 'Wolfsberger CH, Hoeller N, Suppan E, Schwaberger B, Urlesberger B, Nakstad B, Pichler G. Peripheral fractional oxygen extraction measured with near-infrared spectroscopy in neonates-A systematic qualitative review. Front Pediatr. 2022 Aug 23;10:940915. doi: 10.3389/fped.2022.940915. eCollection 2022.'}, {'pmid': '929199', 'type': 'BACKGROUND', 'citation': 'Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early detection of infection/inflammation in neonates. The POP-Score combines peripheral muscle oxygenation measured via near-infrared spectroscopy (NIRS) with routinely monitored clinical parameters (heart rate, oxygen saturation, systolic blood pressure, and subcutaneous fat thickness). The study aims to determine the optimal cut-off value of the POP-Score measured within the first 6 hours after birth to predict elevated C-reactive protein (CRP ≥20 mg/L) within 48 hours. Additionally, multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) will be evaluated to assess their association with inflammation. The study includes term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress, admitted to the neonatal intensive care unit at the Medical University of Graz.', 'detailedDescription': 'Early identification of neonatal infection and inflammation remains a major challenge in neonatal intensive care, particularly in term and moderate-to-late preterm infants with respiratory distress. Current diagnostic approaches rely heavily on clinical symptoms and laboratory markers, which may be subtle or delayed. This study evaluates the diagnostic potential of a novel, non-invasive scoring system-the Peripheral(-muscle) Oxygenation and Perfusion Score (POP-Score)-in predicting elevated C-reactive protein (CRP) levels (≥20 mg/L) within 48 hours after birth.\n\nThe POP-Score integrates near-infrared spectroscopy (NIRS)-based peripheral muscle tissue oxygenation measurements (pTOI) with standard clinical monitoring parameters: arterial oxygen saturation (SpO2), heart rate (HR), systolic arterial blood pressure (SABP), and subcutaneous fat layer thickness (measured by ultrasound). A pilot study demonstrated that a POP-Score \\>1.00 within 6 hours after birth had high sensitivity (100%) and specificity (87%) in predicting elevated CRP values, suggesting potential for early infection screening.\n\nThis is a prospective, single-center, observational Phase II study conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria. Term and moderate-to-late preterm neonates (birth weight ≥2000g) with respiratory distress and risk factors for infection are eligible. Exclusion criteria include severe congenital anomalies, birth weight \\<2000g, age \\>6 hours at time of consent, or umbilical artery pH \\<7.20.\n\nNIRS measurements will be performed within the first 6 hours after birth at four anatomical sites: peripheral muscle (right forearm), cerebral (left forehead), intestinal (infraumbilical), and flank (left posterior flank at T12-L2). Each site will be measured five times using short-duration sensor reapplications to improve data precision. Concurrently, SpO2 and HR (via pulse oximetry), blood pressure, temperature, and subcutaneous fat thickness (via ultrasound) will be recorded. CRP and other laboratory parameters (including leukocyte count, IT-ratio) will be obtained as part of routine care on the first and second day after birth.\n\nThe primary aim is to identify the optimal cut-off level of the POP-Score, calculated within the first 6 hours, to predict CRP ≥20 mg/L within 48 hours. Receiver Operating Characteristic (ROC) analysis will be used, with the area under the curve (AUC) estimated and the optimal cut-off determined via the Youden Index.\n\nSecondary aims include evaluating whether multi-site NIRS measurements (cerebral, peripheral muscle, intestinal, and flank) differ significantly between neonates with CRP ≥20 mg/L and those with CRP \\<20 mg/L, potentially offering additional early indicators of infection or inflammation.\n\nThe target sample size is 93 neonates, assuming a 20% incidence of CRP ≥20 mg/L. This allows estimation of the AUC with a 95% confidence interval and acceptable precision. Data will be analyzed using appropriate statistical tests for categorical and continuous variables. Statistical analyses will be conducted in cooperation with the Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz.\n\nThe POP-Score and multi-site NIRS monitoring offer a potentially powerful, non-invasive approach for early identification of at-risk neonates, enabling earlier intervention and improved outcomes. If validated, this tool may support more accurate and timely clinical decision-making in neonatal intensive care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '0 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term and moderate-to-late preterm neonates (birth weight ≥ 2000 grams) with signs of respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit at the Medical University of Graz. All participants must have a gestational age allowing for clinical stability and must meet inclusion criteria including full life support decision and informed consent obtained within 6 hours of birth.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* birth weight ≥ 2000 grams\n* Signs of respiratory distress at time-point of inclusion (tachypnoea \\>60/min, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory support)\n* Decision to conduct full life support\n* Written informed consent obtained within the first 6 hours after birth, before inclusion in the study\n* Age \\< 6 hours\n\nExclusion Criteria:\n\n* No decision to conduct full life support\n* No written informed consent\n* Birth weight \\< 2000 grams\n* Age \\> 6 hours\n* Severe congenital malformations,\n* Umbilical cord artery pH \\<7.20'}, 'identificationModule': {'nctId': 'NCT07109856', 'acronym': 'POP-Score', 'briefTitle': 'The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'The Peripheral(-Muscle) Oxygenation and Perfusion Score (POPScore) a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates - a Prospective Phase II Observational Study', 'orgStudyIdInfo': {'id': 'POP-Score'}, 'secondaryIdInfos': [{'id': 'Ethical board number 1010/2025', 'type': 'OTHER', 'domain': 'Medical University of Graz'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational cohort', 'description': 'This cohort includes term and moderate-to-late preterm neonates (birth weight ≥ 2000g) with respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit. All enrolled neonates undergo non-invasive monitoring to assess the predictive value of the POP-Score for identifying elevated CRP (≥20 mg/L) within the first 48 hours after birth. The cohort will also be analyzed to evaluate differences in multi-site NIRS measurements (peripheral muscle, cerebral, intestinal, and flank) between those with and without CRP elevation.', 'interventionNames': ['Diagnostic Test: POP-Score Assessment', 'Device: Near-Infrared Spectroscopy (NIRS)']}], 'interventions': [{'name': 'POP-Score Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'A non-invasive score calculated within the first 6 hours after birth using peripheral muscle oxygenation (pTOI, measured via near-infrared spectroscopy), heart rate, arterial oxygen saturation (SpO2), systolic blood pressure (SABP), and subcutaneous fat layer thickness. The score is evaluated for its ability to predict C-reactive protein (CRP) levels ≥ 20 mg/L within 48 hours.', 'armGroupLabels': ['Observational cohort']}, {'name': 'Near-Infrared Spectroscopy (NIRS)', 'type': 'DEVICE', 'description': 'NIRS measurements are performed within 6 hours after birth using the NIRO 200NX device at four anatomical sites (forearm, forehead, infraumbilical region, and left flank). Measurements assess peripheral muscle, cerebral, intestinal, and flank oxygenation to identify possible differences in tissue perfusion associated with early inflammation or infection.', 'armGroupLabels': ['Observational cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University of Graz, Division of Neonatology', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Christina H. Wolfsberger, MD, PhD', 'role': 'CONTACT', 'email': 'christina.wolfsberger@medunigraz.at', 'phone': '+43 316 385 81135'}, {'name': 'Gerhard Pichler, Prof', 'role': 'CONTACT', 'email': 'gerhard.pichler@medunigraz.at'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christina Wolfsberger, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}