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Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Withdrawn
Conditions
Calorie Deficiency
Calorie Overload
Interventions
Device: Monitoring of energy expenditure
Registration Number
NCT03803657
Lead Sponsor
Boston Children's Hospital
Brief Summary

The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
  2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
  3. Assent of patient's intensive care attending physician
  4. Written parental informed consent.
  5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen <80%.
Exclusion Criteria
  1. Clinically significant tracheo-esophageal fistula
  2. Measured ETT leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)
  3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
NeonatesMonitoring of energy expenditureNeonates 0-28 days
ChildMonitoring of energy expenditure\>1 year and \<10 kg
InfantMonitoring of energy expenditure29 days to 1 year
Primary Outcome Measures
NameTimeMethod
Average caloric expenditurethrough study completion, an average of 3 days

Number of calories consumed

Secondary Outcome Measures
NameTimeMethod
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