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Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03154112
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Innovision
Information provided by (Responsible Party):
John Kheir, Boston Children's Hospital

Brief Summary:
The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.

Condition or disease Intervention/treatment
Neonatal Respiratory Failure Congenital Heart Defect Device: Measurement of oxygen consumption and caloric expenditure

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Oxygen consumption [ Time Frame: 1 hour ]
  2. Carbon dioxide production [ Time Frame: 1 hour ]
  3. Respiratory quotient [ Time Frame: 1 hour ]
  4. Resting energy expenditure [ Time Frame: 1 hour ]


Information from the National Library of Medicine

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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
Study Population
Patients will be selected from inpatients in the neonatal or cardiac intensive care unit who are mechanically ventilated.
Criteria

Inclusion criteria.

  1. Mechanically ventilated neonates and infants (<1 year of age).
  2. Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
  3. Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
  4. Written parental informed consent.

Exclusion criteria.

  1. Hemodynamic or respiratory instability.
  2. Patients on extracorporeal membrane oxygenation support.
  3. Clinically significant tracheo-esophageal fistula
  4. Measured endotracheal tube leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Innovision
  Study Documents (Full-Text)

Documents provided by John Kheir, Boston Children's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Kheir, Staff Physician, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03154112    
Other Study ID Numbers: IRB-P00025365
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Defects, Congenital
Respiration Disorders
Respiratory Tract Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities