Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- serum calcium
研究概览
简要总结
The primary aim of this study is to assess whether physical activity programs in preterm infants improve bone mineralization as well as growth and reduce the risk of fractures.
The secondary aim is to include other potential benefits in terms of length of hospital stay, weaning from mechanical ventilation, feeding tolerance and adverse events
详细描述
This is a prospective randomized controlled clinical trial that will be conducted on 36 VLBW preterm infants admitted to the neonatal intensive care unit (NICU) - Ain Shams University
METHODS:
All the newborns included in the study will be subjected to the following:
- Comprehensive history taking including:
- Antenatal history: Maternal age, maternal diseases, maternal diabetic control, maternal infection (STORCH infection), maternal medication during this pregnancy, and last menstrual period.
- Natal history: Gestational age, neonatal sex and mode of delivery.
- Postnatal history: Respiratory distress and cyanosis.
- Family history: Consanguinity, congenital anomalies, previous abortion, sibling death, and still birth.
- Thorough clinical examination with particular emphasis on:
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
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures);
- •Birth weight ≤ 1.500gm;
- •Body size appropriate for gestational age;
- •Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity;
- •Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d.
- •Not requiring oxygen or mechanical ventilation at the start of the exercise protocol.
排除标准
- •Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts);
- •Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.);
- •Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis;
- •Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life
研究组 & 干预措施
physical exercise group
For the exercise group, Intervention by doing physical exercise. systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital.
干预措施: Physical exercise group (Other)
Control group
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
干预措施: Control group (Other)
结局指标
主要结局
serum calcium
时间窗: 2 weeks
mg/dL
ALP
时间窗: 2 weeks
IU/L
serum PO4
时间窗: 2 weeks
mg/dL
serum magnesium
时间窗: 2 weeks
mg/dL
Whole body BMD
时间窗: 2 weeks
mg/cm2
CTX
时间窗: 2 weeks
pg/mL
次要结局
未报告次要终点
研究者
Rania Ali El-Farrash
Associate Professor of Pediatrics
Ain Shams University