Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 10:06 AM
Study NCT ID:
NCT00665769
Status:
TERMINATED
Last Update Posted:
2022-04-05
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D007969', 'term': 'Leukomalacia, Periventricular'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004678', 'term': 'Encephalomalacia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'whyStopped': 'Recruitment was proceeding too slowly', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-22', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of hypercapnia vs. normocapnia on the development of Grade II-IV intraventricular hemorrhage/periventricular leukomalacia (severe brain injury) and/or death', 'timeFrame': 'During first 2 weeks of life (intraventricular hemorrhage and/or death), initial hospitalization for periventricular leukomalacia'}], 'secondaryOutcomes': [{'measure': 'The effect of hypercapnia vs. normocapnia on the development of chronic lung disease (requirement of supplemental oxygen at 36 weeks corrected gestational age)', 'timeFrame': 'By 36 weeks corrected gestational age.'}, {'measure': 'The effect of hypercapnia vs. normocapnia on abnormal results from MRIs', 'timeFrame': 'at term-equivalent age'}, {'measure': 'The effect of hypercapnia vs. normocapnia on the development of pulmonary hemorrhage', 'timeFrame': 'During the initial hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypercapnia', 'normocapnia', 'chronic lung disease', 'periventricular leukomalacia', 'intraventricular hemorrhage', 'hypotension', 'cerebral autoregulation', 'heart rate variability', 'autonomic nervous system', 'detrended fluctuation analysis'], 'conditions': ['Intraventricular Hemorrhage', 'Autoregulation']}, 'referencesModule': {'references': [{'pmid': '18310222', 'type': 'BACKGROUND', 'citation': 'Hall RW, Kaiser JR. Hypotension and brain injury in premature infants. Pediatrics. 2008 Mar;121(3):654; author reply 654-5. doi: 10.1542/peds.2007-3602. No abstract available.'}, {'pmid': '18165829', 'type': 'BACKGROUND', 'citation': 'Kaiser JR, Gauss CH, Williams DK. Tracheal suctioning is associated with prolonged disturbances of cerebral hemodynamics in very low birth weight infants. J Perinatol. 2008 Jan;28(1):34-41. doi: 10.1038/sj.jp.7211848. Epub 2007 Oct 25.'}, {'pmid': '17473113', 'type': 'BACKGROUND', 'citation': 'Kaiser JR. Both extremes of arterial carbon dioxide pressure and the magnitude of fluctuations in arterial carbon dioxide pressure are associated with severe intraventricular hemorrhage in preterm infants. Pediatrics. 2007 May;119(5):1039; author reply 1039-40. doi: 10.1542/peds.2007-0353. No abstract available.'}, {'pmid': '16554847', 'type': 'BACKGROUND', 'citation': 'Kaiser JR, Gauss CH, Pont MM, Williams DK. Hypercapnia during the first 3 days of life is associated with severe intraventricular hemorrhage in very low birth weight infants. J Perinatol. 2006 May;26(5):279-85. doi: 10.1038/sj.jp.7211492.'}, {'pmid': '16257928', 'type': 'BACKGROUND', 'citation': 'Kaiser JR, Gauss CH, Williams DK. The effects of hypercapnia on cerebral autoregulation in ventilated very low birth weight infants. Pediatr Res. 2005 Nov;58(5):931-5. doi: 10.1203/01.pdr.0000182180.80645.0c.'}, {'pmid': '15192631', 'type': 'BACKGROUND', 'citation': 'Kaiser JR, Gauss CH, Williams DK. Surfactant administration acutely affects cerebral and systemic hemodynamics and gas exchange in very-low-birth-weight infants. J Pediatr. 2004 Jun;144(6):809-14. doi: 10.1016/j.jpeds.2004.03.022.'}, {'pmid': '16687424', 'type': 'BACKGROUND', 'citation': 'Tuzcu V, Nas S, Borklu T, Ugur A. Decrease in the heart rate complexity prior to the onset of atrial fibrillation. Europace. 2006 Jun;8(6):398-402. doi: 10.1093/europace/eul031. Epub 2006 May 10.'}, {'pmid': '15693401', 'type': 'BACKGROUND', 'citation': 'Rushing S, Ment LR. Preterm birth: a cost benefit analysis. Semin Perinatol. 2004 Dec;28(6):444-50. doi: 10.1053/j.semperi.2004.10.007.'}, {'pmid': '1392362', 'type': 'BACKGROUND', 'citation': 'van Bel F, de Winter PJ, Wijnands HB, van de Bor M, Egberts J. Cerebral and aortic blood flow velocity patterns in preterm infants receiving prophylactic surfactant treatment. Acta Paediatr. 1992 Jun-Jul;81(6-7):504-10. doi: 10.1111/j.1651-2227.1992.tb12283.x.'}, {'pmid': '1873365', 'type': 'BACKGROUND', 'citation': 'van de Bor M, Walther FJ. Cerebral blood flow velocity regulation in preterm infants. Biol Neonate. 1991;59(6):329-35. doi: 10.1159/000243368.'}, {'pmid': '758388', 'type': 'BACKGROUND', 'citation': 'Lou HC, Lassen NA, Friis-Hansen B. Impaired autoregulation of cerebral blood flow in the distressed newborn infant. J Pediatr. 1979 Jan;94(1):118-21. doi: 10.1016/s0022-3476(79)80373-x.'}, {'pmid': '17272619', 'type': 'BACKGROUND', 'citation': 'Fabres J, Carlo WA, Phillips V, Howard G, Ambalavanan N. Both extremes of arterial carbon dioxide pressure and the magnitude of fluctuations in arterial carbon dioxide pressure are associated with severe intraventricular hemorrhage in preterm infants. Pediatrics. 2007 Feb;119(2):299-305. doi: 10.1542/peds.2006-2434.'}, {'pmid': '16585307', 'type': 'BACKGROUND', 'citation': 'Fanaroff JM, Wilson-Costello DE, Newman NS, Montpetite MM, Fanaroff AA. Treated hypotension is associated with neonatal morbidity and hearing loss in extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1131-5. doi: 10.1542/peds.2005-1230.'}, {'pmid': '1802672', 'type': 'BACKGROUND', 'citation': 'van Ravenswaaij-Arts CM, Hopman JC, Kollee LA, van Amen JP, Stoelinga GB, van Geijn HP. The influence of respiratory distress syndrome on heart rate variability in very preterm infants. Early Hum Dev. 1991 Dec;27(3):207-21. doi: 10.1016/0378-3782(91)90195-9.'}]}, 'descriptionModule': {'briefSummary': 'Annually, almost 5,000 extremely low birth weight (9 ounces to about 2 lbs) infants born in the US survive with severe bleeding in the brain (intraventricular hemorrhage); this devastating complication of prematurity is associated with many problems, including mental retardation, cerebral palsy, and learning disabilities, that result in profound individual and familial consequences. In addition, lifetime care costs for these severely affected infants born in a single year exceed $3 billion. The huge individual and societal costs underscore the need for developing care strategies that may limit severe bleeding in the brain of these tiny infants. The overall goal of our research is to evaluate disturbances of brain blood flow in these tiny infants in order to predict which of them are at highest risk and to develop better intensive care techniques that will limit severe brain injury.\n\n1. Since most of these infants require ventilators (respirators) to survive, we will investigate how 2 different methods of ventilation affect brain injury. We believe that a new method of ventilation, allowing normal carbon dioxide levels, will normalize brain blood flow and lead to less bleeding in the brain.\n2. We will also examine how treatment for low blood pressure in these infants may be associated with brain injury. We believe that most very premature infants with low blood pressure actually do worse if they are treated. We think that by allowing the infants to normalize blood pressure on their own will allow them to stabilize blood flow to the brain leading to less intraventricular hemorrhage.\n3. In 10 premature infants with severe brain bleeding, we have developed a simple technique to identify intraventricular hemorrhage before it happens. Apparently, the heart rate of infants who eventually develop severe intraventricular hemorrhage is less variable than infants who do not develop this. We plan to test this method in a large group of infants, to be able to predict which infants are at highest risk of developing intraventricular hemorrhage and who could most benefit from interventions that would reduce disturbances of brain blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ventilated ELBW (401-1000 grams) infants\n* 23 to 30 weeks' gestation\n* umbilical arterial catheter placed during newborn resuscitation\n\nExclusion Criteria:\n\n* presence of complex congenital anomalies or chromosomal abnormality\n* presence of central nervous system malformation\n* infants with hydrops fetalis\n* infants in extremis\n* infants with early (\\<3 hour of age) intraventricular hemorrhage"}, 'identificationModule': {'nctId': 'NCT00665769', 'acronym': 'PhysDis', 'briefTitle': 'Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Physiological Disturbances Associated With Neonatal Intraventricular Hemorrhage', 'orgStudyIdInfo': {'id': 'H-31475'}, 'secondaryIdInfos': [{'id': '1R01NS060674', 'link': 'https://reporter.nih.gov/quickSearch/1R01NS060674', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Hypercapnia', 'description': 'Hypercapnic ventilation. The goal will be to maintain transcutaneous CO2 55 mm Hg (50-60 mm Hg) during the first week of life, or until extubation. A written, laminated hypercapnic ventilator algorithm will be placed at the bedside.', 'interventionNames': ['Other: Hypercapnia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normocapnia', 'description': 'Normocapnic ventilation. The goal will be to maintain transcutaenous CO2 40 mm Hg (35-45 mm Hg) during the first week of life, or until extubation. A written, laminated normocapnic ventilator algorithm will be placed at the bedside.', 'interventionNames': ['Other: Normocapnia']}], 'interventions': [{'name': 'Hypercapnia', 'type': 'OTHER', 'otherNames': ['hypercarbia', 'permissive hypercapnia'], 'description': 'transcutaenous CO2 50-60 mm Hg', 'armGroupLabels': ['Hypercapnia']}, {'name': 'Normocapnia', 'type': 'OTHER', 'otherNames': ['Normocarbia'], 'description': 'transcutaneous CO2 35-45 mm Hg', 'armGroupLabels': ['Normocapnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jeffrey R. Kaiser, MD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics and Obstetrics and Gynecology', 'investigatorFullName': 'Christopher J. Rhee, MD, MS', 'investigatorAffiliation': 'Baylor University'}}}}