Protein Supplementation Versus Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Participant accrual rate
研究概览
简要总结
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).
详细描述
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 <0
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Premature infants who are less than corrected gestational age of 44 weeks (gestational age + weeks after birth)
- •Were previously enrolled in this trial
- •Are currently enrolled in a potentially confounding trial
- •Diagnosis of anorexia nervosa and other eating disorders
- •On extra-corporeal membrane oxygenation (ECMO) support
- •Conditions that required significant fluid restriction (≤75% of maintenance fluid) (e.g., post cardiac surgery etc.)
研究组 & 干预措施
Standard care group
The participants will receive feeding as per standard of care (without protein or any other supplementations).
Study interventional group
The participants will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds.
干预措施: Enteral protein supplementation (Dietary Supplement)
结局指标
主要结局
Participant accrual rate
时间窗: Throughout the study, over 24 months
Average monthly enrolment at each centre
Proportion of participants receiving their first protein supplementation within 72 hours of enrolment
时间窗: Throughout the study, over 24 months
Number of patients who received protein supplementation within 72 hours of enrolment
Protocol adherence
时间窗: Throughout study period, over 24 months
\>80% of protein target administered according to the protocol in the intervention arm
Proportion of eligible patients approached for consent
时间窗: Throughout study period, over 36 months
Number of eligible patients who are approached for consent
次要结局
- PICU mortality(Throughout study period, over 36 months)
- Adverse events(Throughout study period, over 36 months)
- Change in muscle size(During PICU stay, PICU discharge, hospital discharge and 6 months follow-up)
- Anthropometry(During PICU stay, PICU discharge, hospital discharge and 6 months follow-up)
- PICU length of stay(Throughout study period, over 36 months)
- Hospital length of stay(Throughout the study period, over 36 months)
- Functional status(PICU admission, hospital discharge and 6 months follow-up)
研究者
Jan Hau Lee
Senior Consultant
KK Women's and Children's Hospital