WithdrawnNot Applicable

Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Stopped: Never started

0Started 2023-03-01

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
✓. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
✓. Assent of patient's intensive care attending physician
✓. Written parental informed consent.
✓. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \<80%.

Exclusion criteria

✕. Clinically significant tracheo-esophageal fistula
✕. Measured ETT leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
✕. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.

What they're measuring

Average caloric expenditure

Timeframe: through study completion, an average of 3 days

Trial details

NCT IDNCT03803657

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Calorie Overload trials