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Physical Therapy to Prevent Osteopenia in Preterm Infants

G

Galaad Torró Ferrero

Status

Completed

Conditions

Metabolic Bone Disease

Treatments

Procedure: Massage
Procedure: Passive Joint Mobilizations
Procedure: Reflex Locomotion Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04356807
Fisio-Osteopenia

Details and patient eligibility

About

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

Full description

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.

Enrollment

101 patients

Sex

All

Ages

Under 34 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

101 participants in 3 patient groups, including a placebo group

Reflex Locomotion Therapy
Experimental group
Description:
during 15 minutes once a day five days a week
Treatment:
Procedure: Reflex Locomotion Therapy
Passive Joint Mobilizations
Experimental group
Description:
during 15 minutes once a day five days a week
Treatment:
Procedure: Passive Joint Mobilizations
Massage
Placebo Comparator group
Description:
during 15 minutes once a day five days a week
Treatment:
Procedure: Massage

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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