Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 6
- 主要终点
- Change in Tibial Speed of Sound
研究概览
简要总结
To determine whether reflex locomotion therapy is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods like passive joint mobilizations and massage
详细描述
Premature infants have smaller and low bone mineralization compared with term infants bones, since 80% of calcium uptake occurs at the end of pregnancy. Passive Physiotherapy has been effective in the treatment of osteopenia. Active mobilizations implemented by the baby itself, may be more effective than passive, as they cause muscle contraction from the Central Nervous System (CNS). Reflex locomotion therapy (RLT), stimulates CNS causing muscle contraction so it may be effective in the treatment of osteopenia in premature.
Objectives: To determine whether RLT is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods.
Methodology: Our study is a multicentre randomized clinical trial, with 90 children less than 34 weeks of gestational age, divided into three treatment groups, one will receive RLT, another will be treated with passive joint mobilizations with articular pressure; and last one will be done massage techniques. The treatment will last for one month, for the three groups. We intend to measure changes in mineralization, bone formation, and bone resorption, and anthropometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Care Provider and Outcomes Assessor are masked to the objectives of the study
入排标准
- 年龄范围
- — 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants
- •26 to 34 weeks of gestational age
- •Admitted in neonates
- •Hemodynamically stable
- •Complete enteral nutrition
- •Parents or guardians signed an informed consent authorizing the participation of the baby in this study.
排除标准
- •Neurological disorders
- •Mechanical ventilation
- •Bronchopulmonary dysplasia
- •Congenital malformations
- •Metabolic diseases
- •Genetic diseases
- •Intraventricular hemorrhage III-IV,
- •Diuretic medication or corticosteroids
- •Bone fractures at the time of inclusion.
结局指标
主要结局
Change in Tibial Speed of Sound
时间窗: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
In order to measure bone mineralization, we used the tibial sound velocity test, using for that purpose a quantitative ultrasound device. It was measured on the left tibia in its lower third, while keeping the knee flexed at a 90 degree angle. The measurement point was made perpendicular to the direction of the bone. Three to five consecutive measurements were made, after which the average of these measurements was calculated to have one unique measure in m/s.
Change in Serum biomarkers of Bone-specific phosphatase markers
时间窗: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
N-telopeptides from collagen bonds from serum
Change in Serum biomarkers of osteocalcin markers
时间窗: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
osteocalcin markers
Change in Serum biomarkers of Beta-cross Laps.
时间窗: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Beta-cross Laps.
Change in Urine biomarkers of N-telopeptides from collagen bonds
时间窗: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
N-telopeptides from collagen bonds
次要结局
- Change in Height(Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment))
- Change in Weight(Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment))
- Change in Head circumference(Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment))
研究者
Galaad Torró Ferrero
Principal Investigator
Universidad de Murcia