Protein Supplementation vs Standard Feeds in Underweight Critically Ill Children: A Dual-Centre P… (NCT04565613) | Clinical Trial Compass
CompletedNot Applicable
Protein Supplementation vs Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Pilot RCT
Singapore34 participantsStarted 2021-01-25
Plain-language 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).
Who can participate
Age range28 Days – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Between 28 days and 18 years of age
✓. Have a BMI z-score \< 0 on PICU admission
✓. 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
✓. Requires enteral nutrition support for feeding (e.g., oro-gastric, nasogastric, gastrostomy, naso-jejunal, oro-jejunal)
✓. Have an expected PICU stay of \> 48 hours
Exclusion criteria
✕. Are not expected to survive this PICU admission because of palliative care (e.g., do-not-resuscitate status) or limited life support
✕. Progressive neuromuscular disease (e.g., spinal muscular atrophy, Duchenne or other muscular dystrophy, multiple sclerosis, amyotrophic lateral sclerosis)
✕. Medical conditions where increased or decreased protein intake is required, including acute kidney injury (stage 3 KDIGO criteria), chronic kidney disease (stage 4 and 5), inborn errors of metabolism, fulminant liver failure, severe burn injury
✕. Contraindications to enteral nutrition (e.g., gut hemorrhage, post-gastrointestinal surgery etc.)
✕. Diagnosed cow's milk protein allergy
✕. Parenteral nutrition
What they're measuring
1
Proportion of eligible patients approached for consent
Timeframe: Throughout study period, over 36 months
2
Proportion of participants receiving their first protein supplementation within 72 hours of enrolment
Timeframe: Throughout the study, over 24 months
3
Participant accrual rate
Timeframe: Throughout the study, over 24 months
4
Protocol adherence
Timeframe: Throughout study period, over 24 months