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Trial record 1 of 1 for:    Physical Therapy to Prevent Osteopenia in Preterm Infants
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Physical Therapy to Prevent Osteopenia in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356807
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Galaad Torró Ferrero, Universidad de Murcia

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Metabolic Bone Disease Procedure: Reflex Locomotion Therapy Procedure: Passive Joint Mobilizations Procedure: Massage Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Care Provider and Outcomes Assessor are masked to the objectives of the study
Primary Purpose: Prevention
Official Title: Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants
Actual Study Start Date : February 2016
Actual Primary Completion Date : July 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

Arm Intervention/treatment
Experimental: Reflex Locomotion Therapy
during 15 minutes once a day five days a week
Procedure: Reflex Locomotion Therapy
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.

Experimental: Passive Joint Mobilizations
during 15 minutes once a day five days a week
Procedure: Passive Joint Mobilizations
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008

Placebo Comparator: Massage
during 15 minutes once a day five days a week
Procedure: Massage
Soft massage with soft pressures in limbs, tactile stimulation and no motion.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356807


Locations
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Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Torrecárdenas de Almería
Almería, Spain, 04009
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Sponsors and Collaborators
Galaad Torró Ferrero
Investigators
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Principal Investigator: Galaad Torró-Ferrero, MSc Universidad de Murcia
  Study Documents (Full-Text)

Documents provided by Galaad Torró Ferrero, Universidad de Murcia:
Publications:
El-shaarawy MK, Rahman SAA, Fakher M, El A, Salah WM. Effect of rolling on oxygen saturation and incubation period in preterm neonates with respiratory distress syndrome. Int J Dev Res. 2017;07(01):11319-11323.

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Responsible Party: Galaad Torró Ferrero, Principal Investigator, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT04356807    
Other Study ID Numbers: Fisio-Osteopenia
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galaad Torró Ferrero, Universidad de Murcia:
Premature Infant
Physical Therapy Modalities
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases