Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Boston Children's Hospital

Status: Completed

Conditions: Neonatal Respiratory Failure; Congenital Heart Defect

Treatments: Device: Measurement of oxygen consumption and caloric expenditure

Study type: Observational

Funder types: Other

Identifiers

NCT03154112

IRB-P00025365

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design