Validation of a Novel Oxygen Consumption Measurement Technique in Neonates



Status:Recruiting
Conditions:Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/21/2018
Start Date:July 5, 2017
End Date:December 2018
Contact:John N Kheir, MD
Email:john.kheir@childrens.harvard.edu
Phone:8576368890

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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.


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)
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: John Kheir, MD
Phone: 857-636-8890
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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