Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT00494702
Status:
COMPLETED
Last Update Posted:
2008-10-15
First Post:
2007-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Toxicity in the Resuscitation in Extremely Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001237', 'term': 'Asphyxia'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012151', 'term': 'Resuscitation'}], 'ancestors': [{'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-14', 'studyFirstSubmitDate': '2007-06-28', 'studyFirstSubmitQcDate': '2007-06-28', 'lastUpdatePostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of a targeted saturation of 85% at 15 min of life.', 'timeFrame': '30 min'}], 'secondaryOutcomes': [{'measure': 'Neonatal mortality', 'timeFrame': '28 days of life'}, {'measure': 'Oxidative stress', 'timeFrame': 'at day 1, 2 and 7'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': '36 weeks postconceptional age'}, {'measure': 'Retinopathy of prematurity', 'timeFrame': '40 weeks postconceptional'}, {'measure': 'Neurodevelopment', 'timeFrame': '24 months postnatal'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asphyxia', 'Resuscitation', 'Oxidative stress', 'Prematurity', 'Follow up'], 'conditions': ['Birth Asphyxia', 'Premature Birth']}, 'referencesModule': {'references': [{'pmid': '11335737', 'type': 'BACKGROUND', 'citation': 'Vento M, Asensi M, Sastre J, Garcia-Sala F, Pallardo FV, Vina J. Resuscitation with room air instead of 100% oxygen prevents oxidative stress in moderately asphyxiated term neonates. Pediatrics. 2001 Apr;107(4):642-7. doi: 10.1542/peds.107.4.642.'}, {'pmid': '12537311', 'type': 'BACKGROUND', 'citation': 'Vento M, Asensi M, Sastre J, Lloret A, Garcia-Sala F, Minana JB, Vina J. Hyperoxemia caused by resuscitation with pure oxygen may alter intracellular redox status by increasing oxidized glutathione in asphyxiated newly born infants. Semin Perinatol. 2002 Dec;26(6):406-10. doi: 10.1053/sper.2002.37312.'}, {'pmid': '12640369', 'type': 'BACKGROUND', 'citation': 'Vento M, Asensi M, Sastre J, Lloret A, Garcia-Sala F, Vina J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. J Pediatr. 2003 Mar;142(3):240-6. doi: 10.1067/mpd.2003.91.'}, {'pmid': '12897277', 'type': 'BACKGROUND', 'citation': 'Saugstad OD, Ramji S, Irani SF, El-Meneza S, Hernandez EA, Vento M, Talvik T, Solberg R, Rootwelt T, Aalen OO. Resuscitation of newborn infants with 21% or 100% oxygen: follow-up at 18 to 24 months. Pediatrics. 2003 Aug;112(2):296-300. doi: 10.1542/peds.112.2.296.'}, {'pmid': '15452400', 'type': 'BACKGROUND', 'citation': 'Saugstad OD, Ramji S, Vento M. Resuscitation of depressed newborn infants with ambient air or pure oxygen: a meta-analysis. Biol Neonate. 2005;87(1):27-34. doi: 10.1159/000080950. Epub 2004 Sep 20.'}, {'pmid': '16141440', 'type': 'BACKGROUND', 'citation': 'Vento M, Sastre J, Asensi MA, Vina J. Room-air resuscitation causes less damage to heart and kidney than 100% oxygen. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1393-8. doi: 10.1164/rccm.200412-1740OC. Epub 2005 Sep 1.'}, {'pmid': '16882835', 'type': 'BACKGROUND', 'citation': 'Saugstad OD, Ramji S, Vento M. Oxygen for newborn resuscitation: how much is enough? Pediatrics. 2006 Aug;118(2):789-92. doi: 10.1542/peds.2006-0832. No abstract available.'}, {'pmid': '17426659', 'type': 'BACKGROUND', 'citation': 'Bookatz GB, Mayer CA, Wilson CG, Vento M, Gelfand SL, Haxhiu MA, Martin RJ. Effect of supplemental oxygen on reinitiation of breathing after neonatal resuscitation in rat pups. Pediatr Res. 2007 Jun;61(6):698-702. doi: 10.1203/pdr.0b013e3180534171.'}, {'pmid': '18450889', 'type': 'DERIVED', 'citation': 'Escrig R, Arruza L, Izquierdo I, Villar G, Saenz P, Gimeno A, Moro M, Vento M. Achievement of targeted saturation values in extremely low gestational age neonates resuscitated with low or high oxygen concentrations: a prospective, randomized trial. Pediatrics. 2008 May;121(5):875-81. doi: 10.1542/peds.2007-1984.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.', 'detailedDescription': 'This is a prospective randomized trial enrolling premature infants of less than 28 weeks gestation. Patients are randomly assigned to become resuscitation with an initial oxygen inspiratory fraction (FiO2) of 30% or 90%. Main objective is to reach a target saturation of 85% at 15 min of life.\n\nImmediately after birth pre-and-postductal pulse oximeters are set and oxygen saturation (SpO2) continuously monitored and registered as long as the patient requires oxygen supplementation. FiO2 is stepwise adjusted (increased or decreased 10%) every 90 sec according to heart rate, SpO2 and responsiveness.\n\nBlood samples are drawn from umbilical cord and at day 1, 2 and 7 from peripheral vein to determine oxidative stress markers (GSH, GSSG), angiogenic factors (VEGF, VEGF receptors, Angiopoietin), pro-inflammatory markers (IL8, TNF alfa) and pro-apoptotic markers (Fas Ligand; Cytochrome C).\n\nUrine is collected every day during the first week of life to determine oxidative stress markers (8-oxo-dG; O-tyrosine; F2 isoprostanes; Isofurans).\n\nBabies are followed in the NICU and clinical condition recorded. Serial examinations for ROP and Auditory evoked potentials will be performed. Neurodevelopmental outcome is evaluated at 2 years of postnatal life. Main outcome: Achievement of a target saturation of 85% at 15 min of life. Secondary outcomes: acute complications during delivery; chronic complications (BPD, ROP, IPVH); mortality in the neonatal period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Minutes', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prematurity of less than 28 weeks gestation\n\nExclusion Criteria:\n\n* Severe malformations\n* Chromosomopathies\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT00494702', 'acronym': 'OXTOX', 'briefTitle': 'Oxygen Toxicity in the Resuscitation in Extremely Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Para La Investigacion Hospital La Fe'}, 'officialTitle': 'Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'PIO51O5'}, 'secondaryIdInfos': [{'id': 'FISPI05105'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LOX', 'description': 'Low saturation group of premature infants that will be kept within preset limits of 85-89%', 'interventionNames': ['Procedure: Resuscitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HOX', 'description': 'HOX group of premature infants will be kept within preset saturation limits of 90-93%', 'interventionNames': ['Procedure: Resuscitation']}], 'interventions': [{'name': 'Resuscitation', 'type': 'PROCEDURE', 'description': 'Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%', 'armGroupLabels': ['LOX']}, {'name': 'Resuscitation', 'type': 'PROCEDURE', 'description': 'Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%', 'armGroupLabels': ['HOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Servicio de Neonatologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Maximo Vento, Phd, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Para La Investigacion Hospital La Fe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'INSTITUTO DE SALUD CARLOS III -MINISTERIO DE SANIDAD Y CONSUMO -SPAIN', 'oldOrganization': 'MAXIMO VENTO'}}}}