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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
| Singapore Clinical Research Institute | OTHER |
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
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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).
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:
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 <0. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care group | No Intervention | The participants will receive feeding as per standard of care (without protein or any other supplementations). | |
| Study interventional group | Experimental | The participants will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral protein supplementation | Dietary Supplement | The participants in the study interventional group will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. This will be via 100% whey protein isolate (Nestle Beneprotein). Doses will be calculated on the patient's admission weight and rounded up to the nearest 1g. Doses will not be adjusted to account for weight changes in the PICU. Protein supplementation will continue for a total of 7 days from the start of enrolment into the study or until PICU discharge, whichever is earlier. If the patient is able to take solid feeds during the study intervention period, the intervention will be stopped. However, if the device required for feeding is removed but the patient takes milk/liquid feeds fully, protein supplementation will continue. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eligible patients approached for consent | Number of eligible patients who are approached for consent | Throughout study period, over 36 months |
| Proportion of participants receiving their first protein supplementation within 72 hours of enrolment | Number of patients who received protein supplementation within 72 hours of enrolment | Throughout the study, over 24 months |
| Participant accrual rate | Average monthly enrolment at each centre | Throughout the study, over 24 months |
| Protocol adherence | >80% of protein target administered according to the protocol in the intervention arm | Throughout study period, over 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PICU mortality | Death in PICU | Throughout study period, over 36 months |
| PICU length of stay | Duration of stay in the PICU | Throughout study period, over 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Hau Lee | KK Women's and Children's Hospital, SingHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119228 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34983751 | Derived | Wong JJM, Ong JSM, Ong C, Allen JC, Gandhi M, Fan L, Taylor R, Lim JKB, Poh PF, Chiou FK, Lee JH. Protein supplementation versus standard feeds in underweight critically ill children: a pilot dual-centre randomised controlled trial protocol. BMJ Open. 2022 Jan 4;12(1):e047907. doi: 10.1136/bmjopen-2020-047907. |
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Data from this pilot study may be used for the larger study. If so, these data will not be made available to other researchers till the larger study is completed or deemed not feasible.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomized to enteral protein supplementation or standard care (no enteral protein supplementation) in a 1:1 ratio.
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| Hospital length of stay | Duration of stay in the hospital | Throughout the study period, over 36 months |
| Adverse events | Development of adverse events such as feeding intolerance, diarrhoea, gastrointestinal bleeding | Throughout study period, over 36 months |
| Change in muscle size | Longitudinal change in muscle size as assessed by ultrasound. Muscles for assessment include rectus femoris and diaphragm | During PICU stay, PICU discharge, hospital discharge and 6 months follow-up |
| Anthropometry | Change in anthropometric measurements | During PICU stay, PICU discharge, hospital discharge and 6 months follow-up |
| Functional status | Assessment of functional status via functional status scale (FSS). FSS scores ranged from 6 to 30. A higher score denotes worse outcome | PICU admission, hospital discharge and 6 months follow-up |