NCT00115258已完成3 期
Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Changes in % body fat at baseline, day +30, and day +100.
研究概览
简要总结
The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children undergoing hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents
- •GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids
- •Matched, related or 6/6 HLA-matched unrelated SCT donor
- •Age 6 years and older
排除标准
- •Age less than 6 years, or otherwise unable to comply with study procedures
- •Underweight (body mass index (BMI) z-score <2 for age and sex) at baseline
- •Overweight (BMI z-score >2 for age and sex) at baseline
- •Unable or unwilling to return for day + 100 studies
- •Previous stem cell transplant
- •Unmatched SCT donor
- •Current treatment for hypo- or hyperthyroidism
- •Current insulin dependent diabetes
- •Current use of parenteral nutrition
- •Allergy to egg or soy products
- •Other contraindication to parenteral nutrition at baseline
结局指标
主要结局
Changes in % body fat at baseline, day +30, and day +100.
时间窗: day 30
次要结局
- Resumption of oral intake.(day 30)
- Body composition measured by DXA, BIA, and 4-site skinfolds.(baseline, day 30, and day 100)
- Changes in body composition from baseline to day +100.(day 100)
- Insulin resistance, defined by HOMA, at each time point.(baseline, day 30, and day 100)
- Measured resting energy expenditure (REE) at each time point.(baseline, day 30, and day 100)
- Changes in percent predicted REE between the two groups.(baseline, day 30, and day 100)
- Correlation between body composition and measured REE.(baseline, day 30, and day 100)
研究者
Christopher Duggan
Associate professor of pediatrics
Boston Children's Hospital
相似试验
已完成
不适用
Effects of Parenteral Nutrition in HSCTHematologic MalignancyNCT04425642St. Petersburg State Pavlov Medical University120
终止
2 期
Supplemental Parenteral Nutrition in Pediatric Respiratory FailureAcute Respiratory Failure With HypoxiaMalnutritionNCT01937884University of Arizona18
尚未招募
不适用
Transmural Nutritional Support.NL-OMON21262164
进行中（未招募）
不适用
Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot StudyStem CellNCT06004063M.D. Anderson Cancer Center3
已完成
不适用
Trial of Nutritional Supplementation in Infants Born Small for Gestational AgeBirth WeightNCT00134771Institute of Child Health