Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Congenital Heart Defect Clinical Trial

Official title:

Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154112
• Other study ID #: IRB-P00025365
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Innovision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption		1 hour
Primary	Carbon dioxide production		1 hour
Primary	Respiratory quotient		1 hour
Primary	Resting energy expenditure		1 hour