Current Environment: Production

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.

Conditions

Neonatal Respiratory Failure, Congenital Heart Defect

Recruitment Status

COMPLETED

Eligibility 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)

Intervention

Intervention Type

Intervention Name

DEVICE

Measurement of oxygen consumption and caloric expenditure

Gender

ALL

Min Age

N/A

Max Age

12 Months

Download Date

2020-05-12

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Validation of a Novel Oxygen Consumption Measurement Technique in Neonates NCT03154112