Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-05

Study Completion Date

2019-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Neonatal Respiratory Failure Congenital Heart Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No