Calorie Deficiency Clinical Trial
Official title:
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
NCT number | NCT03803657 |
Other study ID # | IRB-P00030228 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | March 1, 2024 |
Verified date | March 2023 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average caloric expenditure | Number of calories consumed | through study completion, an average of 3 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06376604 -
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
|
N/A | |
Completed |
NCT03440593 -
Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients
|
N/A | |
Completed |
NCT03749668 -
Dietary Survey After Colorectal Surgery Within an Enhanced Recovery Program (DIETERP).
|
||
Completed |
NCT05545943 -
Effects of Calorie Restriction and Cold Stimuli on Health-related Indicators, Cognitive and Motor Functions
|
N/A |