NCT03154112

Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-05
• Primary completion: 2019-01-01
• Completion: 2019-07-01
• First posted: 2017-05-16
• Last updated: 2020-05-12

Locations

1 site across 1 country: United States