Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency

Nutrition Clinical Trial

— NutriCAPE  

Official title:

Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency on Ventilatory Support at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354495
• Other study ID #: P00004109
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: January 26, 2016
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators aim to examine the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support at home. The investigators will use a multidisciplinary model that will allow for diet modification based on comprehensive nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact of this intervention (for 12 weeks) on body composition and respiratory variables will be assessed.

Description:

A strategy of individualized diet intervention and its impact on respiratory and nutritional outcomes in children on long-term mechanical ventilation has not been previously evaluated.

The investigators' objective is to assess the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support using a multidisciplinary model. The investigators will optimize energy intake (based on indirect calorimetric measurement) and protein intake (based on recommended intake values) in this group. The subjects will be administered the modified diet for 12 weeks, and a comprehensive nutrition, metabolic and respiratory assessment will be performed before and after intervention, in the subjects' home. The investigators will examine the effect of individualized diet optimization on nutritional status, body composition, CO2 production (VCO2) and minute ventilation (MV).

The investigators hypothesize that optimizing energy and protein intake would be associated with improved nutritional status, particularly increment in LBM, and decrease in VCO2 and MV. If nutritional optimization is associated with positive outcomes in our study cohort, this concept could be generalized to a wider patient population with respiratory insufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Children aged 1 month to 17 years will be included if they were dependent on at least 12 hours of mechanical ventilation per day via a cuffed tracheostomy tube, with a fractional oxygen requirement (FiO2) less than 0.6, and a leak less than 10% around the cuff at the time of data collection

Exclusion Criteria:

-Intercurrent illness such as fever, seizures and/or infectious disease in the 24 hours preceding the study, and/or respiratory decompensation requiring an increase in ventilator settings of >20% from baseline in the 72 hours preceding the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nutrition
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Dietary Supplement:
• Changes in energy and protein intake
Energy intake will be based on accurate measurements of energy expenditure. Protein intake will be matched to age-based recommended values if necessary.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

References & Publications (1)

Martinez EE, Smallwood CD, Bechard LJ, Graham RJ, Mehta NM. Metabolic assessment and individualized nutrition in children dependent on mechanical ventilation at home. J Pediatr. 2015 Feb;166(2):350-7. doi: 10.1016/j.jpeds.2014.09.036. Epub 2014 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass	change in LBM after 12 weeks of modified diet	12 weeks	No
Primary	Carbon dioxide production (VCO2)	Change in VCO2 (ml/min) after 12 weeks on modified diet	12 weeks	No
Primary	Minute ventilation (L/min)	Change in minute ventilation (L/min) after 12 weeks on modified diet	12 weeks	No