Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-02 @ 6:47 AM
Study NCT ID:
NCT01875159
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2013-06-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026189', 'term': 'caffeine citrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carl.hunt@usuhs.edu', 'phone': '240-694-2676', 'title': 'Carl E. Hunt, M.D.', 'organization': 'Uniformed Services University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day\n\nCaffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.', 'otherNumAtRisk': 42, 'otherNumAffected': 5, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Comparator: no Caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Episodes of Intermittent Hypoxia Per Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day\n\nCaffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.'}, {'id': 'OG001', 'title': 'Active Comparator: no Caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.'}], 'classes': [{'title': 'Week 35', 'categories': [{'measurements': [{'value': '3.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '3.8', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 37', 'categories': [{'measurements': [{'value': '4.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 38', 'categories': [{'measurements': [{'value': '4.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '\\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \\<90% oxygen saturation/hour of recording', 'statisticalMethod': 'GEE gamma regression models', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '35, 36, 37, 38 weeks postmenstrual age', 'description': 'Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation', 'unitOfMeasure': 'Events per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'PRIMARY', 'title': 'Number of Seconds of Intermittent Hypoxia Per Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day\n\nCaffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.'}, {'id': 'OG001', 'title': 'Active Comparator: no Caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.'}], 'classes': [{'title': 'Week 35', 'categories': [{'measurements': [{'value': '50.9', 'spread': '48.1', 'groupId': 'OG000'}, {'value': '106.3', 'spread': '89.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '49.5', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '100.1', 'spread': '114.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 37', 'categories': [{'measurements': [{'value': '58.8', 'spread': '74.1', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '75.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 38', 'categories': [{'measurements': [{'value': '69.3', 'spread': '108.8', 'groupId': 'OG000'}, {'value': '66.0', 'spread': '74.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35, 36, 37, 38 weeks postmenstrual age', 'description': 'Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation', 'unitOfMeasure': 'seconds per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day\n\nCaffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.'}, {'id': 'FG001', 'title': 'Active Comparator: no Caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day\n\nCaffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.'}, {'id': 'BG001', 'title': 'Active Comparator: no Caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '28.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '28.9', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean birth weight', 'classes': [{'categories': [{'measurements': [{'value': '1262.1', 'spread': '265.6', 'groupId': 'BG000'}, {'value': '1274.5', 'spread': '270.3', 'groupId': 'BG001'}, {'value': '1270.1', 'spread': '267.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2013-06-03', 'resultsFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-16', 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodes of Intermittent Hypoxia Per Hour', 'timeFrame': '35, 36, 37, 38 weeks postmenstrual age', 'description': 'Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation'}, {'measure': 'Number of Seconds of Intermittent Hypoxia Per Hour', 'timeFrame': '35, 36, 37, 38 weeks postmenstrual age', 'description': 'Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prematurity', 'Apnea of prematurity', 'Intermittent hypoxia'], 'conditions': ['Hypoxia']}, 'referencesModule': {'references': [{'pmid': '24445955', 'type': 'RESULT', 'citation': 'Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.', 'detailedDescription': 'Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '33 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization\n2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization\n3. Previously tolerated clinical treatment with caffeine\n4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)\n5. Parental consent to enroll in pilot study\n\nExclusion Criteria:\n\n1. Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome\n2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy\n3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped\n4. Anticipated inability to meet protocol requirements'}, 'identificationModule': {'nctId': 'NCT01875159', 'briefTitle': 'Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm', 'organization': {'class': 'OTHER', 'fullName': 'American SIDS Institute'}, 'officialTitle': 'Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm', 'orgStudyIdInfo': {'id': 'ASI 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine', 'description': 'Caffeine citrate 6 mg/kg/day', 'interventionNames': ['Drug: Caffeine citrate 6 mg/kg/day']}, {'type': 'NO_INTERVENTION', 'label': 'Active Comparator: no caffeine', 'description': 'Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.'}], 'interventions': [{'name': 'Caffeine citrate 6 mg/kg/day', 'type': 'DRUG', 'otherNames': ['Cafcit'], 'description': 'Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.', 'armGroupLabels': ['Caffeine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Uniformed Services University of Health Sciences', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Betty McEntire, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American SIDS Instittute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American SIDS Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor of Pediatrics', 'investigatorFullName': 'Carl Hunt', 'investigatorAffiliation': 'American SIDS Institute'}}}}