Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-06 @ 9:57 PM
Study NCT ID:
NCT02605733
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2015-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004569', 'term': 'Electroencephalography'}, {'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'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': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2015-11-12', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG', 'timeFrame': 'Birth to 72 hours of life', 'description': 'amplitude integrated EEG to measure brain activity'}, {'measure': 'NIRS', 'timeFrame': 'Birth to 72 hours of life', 'description': 'Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion'}], 'secondaryOutcomes': [{'measure': 'Apgar scores', 'timeFrame': '1, 5 and 10 minutes of life if applicable', 'description': '1 and 5 minute Apgar scores'}, {'measure': 'Cord gases', 'timeFrame': 'Upon delivery', 'description': 'Arterial or venous pH (acid/base), base deficit'}, {'measure': 'Resuscitation intervention', 'timeFrame': 'From birth to 10 minutes of life', 'description': 'Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.'}, {'measure': 'Maximum FiO2', 'timeFrame': 'From birth to 10 minutes of life', 'description': 'Maximum FiO2 during resuscitation at birth'}, {'measure': 'Maximum peak inspiratory pressure', 'timeFrame': 'From birth to 10 minutes of life', 'description': 'Peak inspiratory pressure of respiratory support'}, {'measure': 'Heart rate', 'timeFrame': 'Birth to 72 hours of life'}, {'measure': 'Heart rate by EKG during resuscitation (substudy)', 'timeFrame': 'Birth', 'description': 'A substudy of 40 infants will have EKG leads placed on newborns during resuscitation; 20 will have the display blinded, and 20 will have values available to the team. The amount of resuscitation (mean airway pressure FiO2 will be compared between groups).'}, {'measure': 'Cardiac output', 'timeFrame': 'From neonatal intensive care unit (NICU) admission through 72 hours of life'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': 'From NICU admission through 72 hours of life'}, {'measure': 'Use of cardiac inotropes', 'timeFrame': 'From birth through discharge to home, up to 9 months of age', 'description': 'Dopamine, dobutamine, epinephrine'}, {'measure': 'Head Ultrasound', 'timeFrame': 'Within 24 hours of life and at approximately 72 hours of life', 'description': 'Cranial ultrasonography'}, {'measure': 'MRI', 'timeFrame': 'From birth through discharge to home, up to 9 months of age', 'description': 'Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL)'}, {'measure': 'Neurodevelopmental impairment at 2 year follow up', 'timeFrame': '18 to 30 months corrected gestational age', 'description': 'Neurodevelopmental assessment at 2 year corrected gestational age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature infant', 'Amplitude integrated EEG', 'Near-infrared spectroscopy'], 'conditions': ['Neurologic Manifestations', 'Premature Birth', 'Hypoxia-Ischemia, Brain']}, 'referencesModule': {'references': [{'pmid': '25594221', 'type': 'BACKGROUND', 'citation': 'Peng S, Boudes E, Tan X, Saint-Martin C, Shevell M, Wintermark P. Does near-infrared spectroscopy identify asphyxiated newborns at risk of developing brain injury during hypothermia treatment? Am J Perinatol. 2015 May;32(6):555-64. doi: 10.1055/s-0034-1396692. Epub 2015 Jan 16.'}, {'pmid': '18650042', 'type': 'BACKGROUND', 'citation': 'Ancora G, Maranella E, Locatelli C, Pierantoni L, Faldella G. Changes in cerebral hemodynamics and amplitude integrated EEG in an asphyxiated newborn during and after cool cap treatment. Brain Dev. 2009 Jun;31(6):442-4. doi: 10.1016/j.braindev.2008.06.003. Epub 2008 Jul 22.'}, {'pmid': '22082686', 'type': 'BACKGROUND', 'citation': 'Ancora G, Maranella E, Grandi S, Sbravati F, Coccolini E, Savini S, Faldella G. Early predictors of short term neurodevelopmental outcome in asphyxiated cooled infants. A combined brain amplitude integrated electroencephalography and near infrared spectroscopy study. Brain Dev. 2013 Jan;35(1):26-31. doi: 10.1016/j.braindev.2011.09.008. Epub 2011 Nov 13.'}, {'pmid': '21741190', 'type': 'BACKGROUND', 'citation': 'Gucuyener K, Beken S, Ergenekon E, Soysal S, Hirfanoglu I, Turan O, Unal S, Altuntas N, Kazanci E, Kulali F, Koc E, Turkyilmaz C, Onal E, Atalay Y. Use of amplitude-integrated electroencephalography (aEEG) and near infrared spectroscopy findings in neonates with asphyxia during selective head cooling. Brain Dev. 2012 Apr;34(4):280-6. doi: 10.1016/j.braindev.2011.06.005. Epub 2011 Jul 7.'}, {'pmid': '19150756', 'type': 'BACKGROUND', 'citation': 'Toet MC, Lemmers PM. Brain monitoring in neonates. Early Hum Dev. 2009 Feb;85(2):77-84. doi: 10.1016/j.earlhumdev.2008.11.007. Epub 2009 Jan 17.'}, {'pmid': '20877412', 'type': 'BACKGROUND', 'citation': 'Tao JD, Mathur AM. Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93.'}, {'pmid': '21852771', 'type': 'BACKGROUND', 'citation': 'Fuchs H, Lindner W, Buschko A, Almazam M, Hummler HD, Schmid MB. Brain oxygenation monitoring during neonatal resuscitation of very low birth weight infants. J Perinatol. 2012 May;32(5):356-62. doi: 10.1038/jp.2011.110. Epub 2011 Aug 18.'}, {'pmid': '24560179', 'type': 'BACKGROUND', 'citation': 'Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.'}, {'pmid': '24709780', 'type': 'BACKGROUND', 'citation': 'Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.'}, {'pmid': '24183212', 'type': 'BACKGROUND', 'citation': 'Noori S, McCoy M, Anderson MP, Ramji F, Seri I. Changes in cardiac function and cerebral blood flow in relation to peri/intraventricular hemorrhage in extremely preterm infants. J Pediatr. 2014 Feb;164(2):264-70.e1-3. doi: 10.1016/j.jpeds.2013.09.045. Epub 2013 Oct 30.'}, {'pmid': '22254711', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Chan GS, Tracy MB, Lee QY, Hinder M, Savkin AV, Lovell NH. Cerebral near-infrared spectroscopy analysis in preterm infants with intraventricular hemorrhage. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1937-40. doi: 10.1109/IEMBS.2011.6090547.'}, {'pmid': '25003781', 'type': 'BACKGROUND', 'citation': 'Song J, Zhu C, Xu F, Guo J, Zhang Y. Predictive value of early amplitude-integrated electroencephalography for later diagnosed cerebral white matter damage in preterm infants. Neuropediatrics. 2014 Oct;45(5):314-20. doi: 10.1055/s-0034-1382823. Epub 2014 Jul 8.'}, {'pmid': '24867393', 'type': 'BACKGROUND', 'citation': 'Benders MJ, Palmu K, Menache C, Borradori-Tolsa C, Lazeyras F, Sizonenko S, Dubois J, Vanhatalo S, Huppi PS. Early Brain Activity Relates to Subsequent Brain Growth in Premature Infants. Cereb Cortex. 2015 Sep;25(9):3014-24. doi: 10.1093/cercor/bhu097. Epub 2014 May 27.'}, {'pmid': '23313424', 'type': 'BACKGROUND', 'citation': 'Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.'}, {'pmid': '29680471', 'type': 'DERIVED', 'citation': 'Katheria AC, Harbert MJ, Nagaraj SB, Arnell K, Poeltler DM, Brown MK, Rich W, Hassen KO, Finer N. The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study. J Pediatr. 2018 Jul;198:209-213.e3. doi: 10.1016/j.jpeds.2018.02.065. Epub 2018 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.', 'detailedDescription': 'The investigators will measure components of brain function using two sophisticated, non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a "simplified" EEG with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. Both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants delivered at 23 to 31 +6 weeks gestational age at Sharp MBHWN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 23 to 31+6 weeks gestational age at birth\n\nExclusion Criteria:\n\n* Known congenital anomalies\n* Parents refuse consent\n* Neonatologist declined due to subject instability'}, 'identificationModule': {'nctId': 'NCT02605733', 'acronym': 'Neu-Prem', 'briefTitle': 'The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation', 'orgStudyIdInfo': {'id': 'Neu-Prem'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EEG', 'type': 'DEVICE', 'otherNames': ['amplitude integrated electroencephalography'], 'description': 'amplitude integrated electroencephalography'}, {'name': 'NIRS', 'type': 'DEVICE', 'otherNames': ['Near-infrared spectroscopy'], 'description': 'regional tissue oximetry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women and Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Anup Katheria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp HealthCare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Neonatal Research', 'investigatorFullName': 'Anup Katheria, M.D.', 'investigatorAffiliation': 'Sharp HealthCare'}}}}