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

NCT02354495 | Completed

• 1 other identifier: P00004109
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nutrition

Keywords

Indirect calorimetry; Protein; Mechanical ventilation; Respiratory failure

Outcome Measures

Primary Outcomes (3)

• Lean body mass

  change in LBM after 12 weeks of modified diet

  12 weeks

• Carbon dioxide production (VCO2)

  Change in VCO2 (ml/min) after 12 weeks on modified diet

  12 weeks

• Minute ventilation (L/min)

  Change in minute ventilation (L/min) after 12 weeks on modified diet

  12 weeks

Study Arms (1)

Diet intervention arm

EXPERIMENTAL

Individualized diet prescription following food record, indirect calorimetry (for energy requirement) and body composition assessments. repeat assessments after 12 weeks on interventional diet.

Dietary Supplement: Changes in energy and protein intake

Interventions

Changes in energy and protein intake DIETARY_SUPPLEMENT

Energy intake will be based on accurate measurements of energy expenditure. Protein intake will be matched to age-based recommended values if necessary.

Diet intervention arm

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related 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.

  PMID: 25444009 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesia, Critical Care

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01