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Recruiting NCT04565613

Protein Supplementation vs Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Pilot RCT

Trial Parameters

Condition Critically Ill
Sponsor KK Women's and Children's Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 28 Days
Max Age 18 Years
Start Date 2021-01-25
Completion 2024-09
Interventions
Enteral protein supplementation

Brief Summary

This pilot trial is part of a long-term research program leading to a large trial to determine if a strategy of supplementing protein in a subset of critically ill children is superior to standard enteral nutrition care. The investigators hypothesize that protein supplementation to critically ill children with body mass index (BMI) z-score \<0 reduces the length of stay in the paediatric intensive care unit (PICU) and hospital, as well as the duration of mechanical ventilation (MV).

Eligibility Criteria

Inclusion Criteria: 1. Between 28 days and 18 years of age 2. Have a BMI z-score \< 0 on PICU admission 3. Requires respiratory support in the form of invasive or non-invasive mechanical ventilation (CPAP or BiPAP) within 24-48 hours of PICU admission, and the attending physician expects the child to require any respiratory support for at least 48 hours of PICU admission 4. Requires enteral nutrition support for feeding (e.g., oro-gastric, nasogastric, gastrostomy, naso-jejunal, oro-jejunal) 5. Have an expected PICU stay of \> 48 hours Exclusion Criteria: 1. Are not expected to survive this PICU admission because of palliative care (e.g., do-not-resuscitate status) or limited life support 2. Progressive neuromuscular disease (e.g., spinal muscular atrophy, Duchenne or other muscular dystrophy, multiple sclerosis, amyotrophic lateral sclerosis) 3. Medical conditions where increased or decreased protein intake is required, including acute kidney injury (stage 3 KDIGO criteria), chronic k

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