Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Completed

• Conditions: Neonatal Respiratory Failure; Congenital Heart Defect

• Registration Number: NCT03154112
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2017-07-05
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory quotient	1 hour
Oxygen consumption	1 hour
Carbon dioxide production	1 hour
Resting energy expenditure	1 hour

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States