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Completed

NCT Number: NCT03154112

Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

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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Key information

Conditions

Neonatal Respiratory Failure Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Defect Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

.

  • Mechanically ventilated neonates and infants (<1 year of age).
  • Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
  • Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
  • Written parental informed consent.

Exclusion criteria

.

  • Hemodynamic or respiratory instability.
  • Patients on extracorporeal membrane oxygenation support.
  • Clinically significant tracheo-esophageal fistula
  • Measured endotracheal tube leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)

Treatment and study plan

Measurement of oxygen consumption and caloric expenditure

Device

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.

Primary outcomes

  1. Oxygen consumption

    Time frame: 1 hour

  2. Carbon dioxide production

    Time frame: 1 hour

  3. Respiratory quotient

    Time frame: 1 hour

  4. Resting energy expenditure

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Innovision

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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