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

Launched by KK WOMEN'S AND CHILDREN'S HOSPITAL · Sep 22, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring whether adding extra protein to the diets of critically ill children can help them recover faster compared to standard feeding methods. The study is especially focused on children who are underweight, as indicated by their body mass index (BMI) scores. Researchers believe that providing more protein might reduce the time these children spend in the pediatric intensive care unit (PICU), shorten their hospital stays, and decrease the time they need assistance with breathing through machines.

To be part of this trial, children must be between 28 days and 18 years old, have a BMI score that is below normal when they enter the PICU, and need help with breathing and feeding. The trial is currently looking for participants, and children who meet these criteria can expect to receive either the standard nutrition or the protein supplement as part of their care. It's important to know that certain medical conditions may make children ineligible for this study, such as serious illnesses that affect their ability to eat or survive.

Gender

ALL

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 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.)