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Completed

NCT Number: NCT04356807

Physical Therapy to Prevent Osteopenia in Preterm Infants

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

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Key information

Conditions

Metabolic Bone Disease Bone Diseases Bone Diseases, Metabolic Female Urogenital Diseases and Pregnancy Complications Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Elche, Elche, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflex Locomotion Therapy

Procedure

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.

Passive Joint Mobilizations

Procedure

Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008

Massage

Procedure

Soft massage with soft pressures in limbs, tactile stimulation and no motion.

Primary outcomes

  1. Change in Tibial Speed of Sound

    Time frame: 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.

  2. Change in Serum biomarkers of Bone-specific phosphatase markers

    Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

    N-telopeptides from collagen bonds from serum

  3. Change in Serum biomarkers of osteocalcin markers

    Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

    osteocalcin markers

  4. Change in Serum biomarkers of Beta-cross Laps.

    Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

    Beta-cross Laps.

  5. Change in Urine biomarkers of N-telopeptides from collagen bonds

    Time frame: 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

Secondary outcomes

  1. Change in Height

    Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

    For anthropometry, height in cm were collected

  2. Change in Weight

    Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

    measurements of weight in grams were collected

  3. Change in Head circumference

    Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

    For anthropometry, measurements of head circumference in cm were collected

Sponsors and collaborators

Lead sponsor

Galaad Torró Ferrero

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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