Protein Supplementation in Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critically Ill
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized to enteral protein supplementation or standard care (no enteral protein supplementation) in a 1:1 ratio.Masking: Single (Outcomes Assessor)Masking Description: Only clinical outcome assessors and statisticians will be blinded to the assigned arm/group.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Younger than 18 years
- Gender
- Both males and females
Description
Protein malnutrition is prevalent among critically ill children and associated with poor clinical outcomes. Current guidelines for provision of protein in daily management of critically ill children in pediatric intensive care units (PICUs) are based on limited and not high-quality evidence. The cur...
Protein malnutrition is prevalent among critically ill children and associated with poor clinical outcomes. Current guidelines for provision of protein in daily management of critically ill children in pediatric intensive care units (PICUs) are based on limited and not high-quality evidence. The current protein supplementation approach, "one-size-fits-all" nutrition prescription, may not be appropriate for every critically ill child. Given the heterogeneity of the patients admitted to the PICU, a targeted approach based on individuals' needs represents a potential advancement in PICU care. The central hypothesis is that protein supplementation in PICU care leads to improved clinical outcomes in subgroups of patients only. The investigators propose a dual-centre pilot randomized controlled trial in Singapore with two major aims: To obtain key information for planning and conducting a large-scale multicentre study in Asia; and to evaluate the benefit of protein supplementation to critically ill children with body mass index (BMI) z-scores on PICU ? -2. The main clinical outcome of interest is total number of days of hospital stay (from PICU admission to hospital discharge). Two protein supplementation regimes (? 1.5g/kg/day vs. standard care) will be randomly allocated to PICU patients with body mass index (BMI) z-scores ? -2. The investigators will determine the effect of protein supplementation on total length of hospital stay and other clinical outcomes, and assess the impact of protein supplementation on acquired functional impairment of PICU survivors 6 months after hospital discharge. In addition, the investigators will explore whether muscle ultrasound is a biomarker for protein balance in pediatric critical illness. Upon completion of this study, the investigators will have strong preliminary data to plan, refine their study approach, and execute a future large multi-centre study across Asia. These data will ultimately guide protein provision and nutritional management of patients in PICU setting.
Tracking Information
- NCT #
- NCT04565613
- Collaborators
- Duke-NUS Graduate Medical School
- Singapore Clinical Research Institute
- National Medical Research Council (NMRC), Singapore
- Investigators
- Principal Investigator: Jan Hau Lee KK Women's and Children's Hospital, SingHealth