Protein supplementation for underweight critically ill children
Protein Supplementation Versus Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial
This study is testing if giving extra protein to underweight critically ill children can help them recover faster and spend less time in the hospital compared to regular nutrition care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 28 Days to 18 Years |
| Sex | All |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04565613 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates whether protein supplementation in critically ill children with a BMI z-score below zero can improve clinical outcomes compared to standard nutrition care. The study aims to determine if higher protein intake reduces the length of stay in the pediatric intensive care unit (PICU) and hospital, as well as the duration of mechanical ventilation. Conducted at two centers in Singapore, the trial will randomly assign participants to receive either standard care or enhanced protein supplementation. The findings will inform a larger multicenter study in Asia.
Who should consider this trial
Good fit: Ideal candidates are critically ill children aged 28 days to 18 years with a BMI z-score below zero who require respiratory support and enteral nutrition.
Not a fit: Patients not expected to survive their PICU admission or those with specific medical conditions requiring altered protein intake may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and outcomes for critically ill children with protein malnutrition.
How similar studies have performed: While this approach is based on existing knowledge of protein malnutrition in critically ill children, the specific strategy of targeted protein supplementation is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 kidney disease (stage 4 and 5), inborn errors of metabolism, fulminant liver failure, severe burn injury 4. Contraindications to enteral nutrition (e.g., gut hemorrhage, post-gastrointestinal surgery etc.) 5. Diagnosed cow's milk protein allergy 6. Parenteral nutrition 7. Premature infants who are less than corrected gestational age of 44 weeks (gestational age + weeks after birth) 8. Were previously enrolled in this trial 9. Are currently enrolled in a potentially confounding trial 10. Diagnosis of anorexia nervosa and other eating disorders 11. On extra-corporeal membrane oxygenation (ECMO) support 12. Conditions that required significant fluid restriction (≤75% of maintenance fluid) (e.g., post cardiac surgery etc.)
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Jan Hau Lee — KK Women's and Children's Hospital, SingHealth
- Study coordinator: Jan Hau Lee
- Email: lee.jan.hau@singhealth.com.sg
- Phone: 63926347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.