Assisted Exercise in Prematurity; Effects and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Body composition, bone mineralization, muscle mass, anthropometric measurements
研究概览
简要总结
Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body composition and neurological/behavioral development of healthy growing premature infants enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets the exercise intervention and the control group is cuddled for the same amount of time -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth hormone. Video of each subject is recorded an hour at two time points during the study to assess the babies for spontaneous activity. Nutritional intake information is collected daily and in the 4th week of the study assessments made for total energy expenditure using doubly labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison. Finally in the period just before discharge we do a complex neurological exam using the Brazelton NBAS assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at post menstrual ages of 23-33 weeks gestation Enrollment occurs at post menstrual age of 30 to 35 weeks.if their projected stay based on standard clinical criteria is four weeks after enrollment
- •Enrollment occurs at post menstrual age of 30 up to 35 weeks, if their projected stay based on standard clinical criteria is 4 weeks after enrollment.
- •Birth weight appropriate for gestational age (AGA) using current CDC growth charts. AGA is defined as plus or minus 2 standard deviations above the mean or above the third percentile.
- •Tolerating full enteral feeds at greater than or equal to 100kcal/kg/day
排除标准
- •Evidence of chromosomal or other major genetic abnormalities
- •Existence of current diseases or syndromes including:
- •central nervous system or other neurological abnormalities chronic lung disease of prematurity requiring chronic use of corticosteroids, musculoskeletal diseases
- •positive infant toxicology screen(urine) for drugs or alcohol
- •Both parents are under the age of 18 years
- •Babies with tracheostomy
- •Babies receiving ventilator assistance with breathing
- •Babies receiving IV fluids
研究组 & 干预措施
1
4 weeks of assisted exercise using passive range of motion on all major joints
干预措施: assisted exercise (Other)
2
cuddle for 20 minutes
干预措施: cuddle (Other)
结局指标
主要结局
Body composition, bone mineralization, muscle mass, anthropometric measurements
时间窗: 4 weeks
次要结局
- spontaneous movement(two time points)
- Neurological/behavioral status(end of 4th week)
- Blood Sampling to measure IGF-1, GHBP, IL-1ra(Baseline, week 2 and week 4)