Physical Therapy to Prevent Osteopenia in Preterm Infants

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants

Conditions
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Metabolic Bone Disease

Intervention / Treatment
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* Procedure: Reflex Locomotion Therapy
* Procedure: Passive Joint Mobilizations
* Procedure: Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflex Locomotion Therapy<br>during 15 minutes once a day five days a week | Procedure: Reflex Locomotion Therapy<br>* The exercises corresponding to the motor complexes of the 1st phase of the rolling reflex and the original creeping reflex were performed, dedicating one minute to each side and performing two repetitions in each session.<br>|
| Experimental: Passive Joint Mobilizations<br>during 15 minutes once a day five days a week | Procedure: Passive Joint Mobilizations<br>* Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008<br>|
| Placebo Comparator: Massage<br>during 15 minutes once a day five days a week | Procedure: Massage<br>* Soft massage with soft pressures in limbs, tactile stimulation and no motion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tibial Speed of Sound | 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 measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 
| Change in Serum biomarkers of Bone-specific phosphatase markers | N-telopeptides from collagen bonds from serum | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | 
| Change in Serum biomarkers of osteocalcin markers | osteocalcin markers | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | 
| Change in Serum biomarkers of Beta-cross Laps. | Beta-cross Laps. | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | 
| Change in Urine biomarkers of N-telopeptides from collagen bonds | N-telopeptides from collagen bonds | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Height | For anthropometry, height in cm were collected | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 
| Change in Weight | measurements of weight in grams were collected | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 
| Change in Head circumference | For anthropometry, measurements of head circumference in cm were collected | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infant, Physical Therapy Modalities