Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Calorie Deficiency Clinical Trial

Official title:

Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03803657
• Other study ID #: IRB-P00030228
• Status: Withdrawn
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Calorie Deficiency
• Calorie Overload

Intervention

Device:
• Monitoring of energy expenditure
Continuous monitoring of energy expenditure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

References & Publications (1)

Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average caloric expenditure	Number of calories consumed	through study completion, an average of 3 days