Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:07 PM
Study NCT ID:
NCT03803657
Status:
WITHDRAWN
Last Update Posted:
2023-03-09
First Post:
2019-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average caloric expenditure', 'timeFrame': 'through study completion, an average of 3 days', 'description': 'Number of calories consumed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Calorie Overload', 'Calorie Deficiency']}, 'referencesModule': {'references': [{'pmid': '29505450', 'type': 'BACKGROUND', 'citation': 'Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated children.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg\n2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit\n3. Assent of patient's intensive care attending physician\n4. Written parental informed consent.\n5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \\<80%.\n\nExclusion Criteria:\n\n1. Clinically significant tracheo-esophageal fistula\n2. Measured ETT leak \\>20% (i.e. difference between inspiratory and expiratory tidal volumes)\n3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation."}, 'identificationModule': {'nctId': 'NCT03803657', 'briefTitle': 'Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates', 'orgStudyIdInfo': {'id': 'IRB-P00030228'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonates', 'description': 'Neonates 0-28 days', 'interventionNames': ['Device: Monitoring of energy expenditure']}, {'label': 'Infant', 'description': '29 days to 1 year', 'interventionNames': ['Device: Monitoring of energy expenditure']}, {'label': 'Child', 'description': '\\>1 year and \\<10 kg', 'interventionNames': ['Device: Monitoring of energy expenditure']}], 'interventions': [{'name': 'Monitoring of energy expenditure', 'type': 'DEVICE', 'description': 'Continuous monitoring of energy expenditure.', 'armGroupLabels': ['Child', 'Infant', 'Neonates']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff physician', 'investigatorFullName': 'John Kheir', 'investigatorAffiliation': "Boston Children's Hospital"}}}}