Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-04 @ 6:12 PM
Study NCT ID:
NCT01697904
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2012-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003696', 'term': 'Delivery Rooms'}], 'ancestors': [{'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-01', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in mean oxidative balance ratio at 1 hour of life', 'timeFrame': 'Cord blood and at 1 hour of life', 'description': 'Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.'}], 'secondaryOutcomes': [{'measure': 'Total oxygen load used during active resuscitation', 'timeFrame': 'First 10 minutes of life'}, {'measure': 'Saturations achieved during first 10 minutes of life', 'timeFrame': 'First 10 minutes of life'}, {'measure': 'Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation', 'timeFrame': 'First 10 minutes of life'}, {'measure': 'Time spent with saturation above 94% during active resuscitation', 'timeFrame': 'First 10 minutes of life'}, {'measure': 'Need for respiratory support in the delivery room', 'timeFrame': 'First 10 minutes of life'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': '36 weeks postconceptional age'}, {'measure': 'Length of hospitalization', 'timeFrame': 'From date of randomization to date of discharge, expected average of 8 weeks'}, {'measure': 'Retinopathy of Prematurity', 'timeFrame': '40 weeks postconceptional age'}, {'measure': 'Neonatal mortality', 'timeFrame': '28 days of life'}, {'measure': 'Death before discharge', 'timeFrame': 'From date of randomization to date of discharge, expected average of 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prematurity', 'Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '24218465', 'type': 'DERIVED', 'citation': 'Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013 Dec;132(6):e1488-96. doi: 10.1542/peds.2013-0978. Epub 2013 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn\n* Gestation age 24 0/7 to 34 6/7\n* Need for active resuscitation\n\nExclusion Criteria:\n\n* Prenatally diagnosed cyanotic congenital heart disease\n* Non-viable newborns\n* Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation'}, 'identificationModule': {'nctId': 'NCT01697904', 'briefTitle': 'Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns', 'orgStudyIdInfo': {'id': 'STU 052011-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Oxygen Strategy', 'description': 'Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR \\< 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized.\n\nTargeted Pre-ductal SpO2 After birth\n\n1. min 60%-65%\n2. min 65%-70%\n3. min 70%-75%\n4. min 75%-80%\n5. min 80%-85%\n\n10 min 85%-94%', 'interventionNames': ['Procedure: Titration of oxygen during newborn resuscitation in delivery room']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Oxygen strategy ( TOX)', 'description': 'Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%', 'interventionNames': ['Procedure: Titration of oxygen during newborn resuscitation in delivery room']}], 'interventions': [{'name': 'Titration of oxygen during newborn resuscitation in delivery room', 'type': 'PROCEDURE', 'armGroupLabels': ['Low Oxygen Strategy', 'Traditional Oxygen strategy ( TOX)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Vishal S Kapadia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}, {'name': 'Myra H Wyckoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Vishal Kapadia', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}