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Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803657
Enrollment
0
Registered
2019-01-14
Start date
2023-03-01
Completion date
2024-03-01
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calorie Deficiency, Calorie Overload

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.

Interventions

DEVICEMonitoring of energy expenditure

Continuous monitoring of energy expenditure.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Average caloric expenditurethrough study completion, an average of 3 daysNumber of calories consumed

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026