Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
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|ClinicalTrials.gov Identifier: NCT03154112|
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 12, 2020
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|Condition or disease||Intervention/treatment|
|Neonatal Respiratory Failure Congenital Heart Defect||Device: Measurement of oxygen consumption and caloric expenditure|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Validation of a Novel Oxygen Consumption Measurement Technique in Neonates|
|Actual Study Start Date :||July 5, 2017|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
- Device: Measurement of oxygen consumption and caloric expenditure
This study will involve an ~1 hour, single point in time measurement of oxygen consumption, carbon dioxide production, resting energy expenditure, and respiratory quotient using two methods while patients are breathing an FiO2 of 40%. These measurements will be measured using the novel, responsive device and compared with gas collected simultaneously collected from a Douglas bag.
- Oxygen consumption [ Time Frame: 1 hour ]
- Carbon dioxide production [ Time Frame: 1 hour ]
- Respiratory quotient [ Time Frame: 1 hour ]
- Resting energy expenditure [ Time Frame: 1 hour ]
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|Ages Eligible for Study:||up to 12 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Mechanically ventilated neonates and infants (<1 year of age).
- Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
- Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
- Written parental informed consent.
- Hemodynamic or respiratory instability.
- Patients on extracorporeal membrane oxygenation support.
- Clinically significant tracheo-esophageal fistula
- Measured endotracheal tube leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154112
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
Documents provided by John Kheir, Boston Children's Hospital:
|Responsible Party:||John Kheir, Staff Physician, Boston Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||May 16, 2017 Key Record Dates|
|Last Update Posted:||May 12, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Heart Defects, Congenital
Respiratory Tract Diseases