Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Boston Children's Hospital

Status: Withdrawn

Conditions: Calorie Overload; Calorie Deficiency

Treatments: Device: Monitoring of energy expenditure

Study type: Observational

Funder types: Other

Identifiers

NCT03803657

IRB-P00030228

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

Neonates

Description:

Neonates 0-28 days

Treatment:

Device: Monitoring of energy expenditure

Infant

Description:

29 days to 1 year

Treatment:

Device: Monitoring of energy expenditure

Child

Description:

\>1 year and \<10 kg

Treatment:

Device: Monitoring of energy expenditure