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Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants

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ClinicalTrials.gov Identifier: NCT03354988
Recruitment Status : Unknown
Verified May 2018 by Rania Ali El-Farrash, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University

Brief Summary:

The primary aim of this study is to assess whether physical activity programs in preterm infants improve bone mineralization as well as growth and reduce the risk of fractures.

The secondary aim is to include other potential benefits in terms of length of hospital stay, weaning from mechanical ventilation, feeding tolerance and adverse events


Condition or disease Intervention/treatment Phase
Osteopenia Prematurity Other: Physical exercise group Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: physical exercise group
For the exercise group, Intervention by doing physical exercise. systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital.
Other: Physical exercise group
For the exercise group, systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital

Control group
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
Other: Control group
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control




Primary Outcome Measures :
  1. serum calcium [ Time Frame: 2 weeks ]
    mg/dL

  2. serum PO4 [ Time Frame: 2 weeks ]
    mg/dL

  3. serum magnesium [ Time Frame: 2 weeks ]
    mg/dL

  4. ALP [ Time Frame: 2 weeks ]
    IU/L

  5. CTX [ Time Frame: 2 weeks ]
    pg/mL

  6. Whole body BMD [ Time Frame: 2 weeks ]
    mg/cm2



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures);
  • Birth weight ≤ 1.500gm;
  • Body size appropriate for gestational age;
  • Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity;
  • Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d.
  • Not requiring oxygen or mechanical ventilation at the start of the exercise protocol.

Exclusion Criteria:

  • Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts);
  • Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.);
  • Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis;
  • Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life

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): NCT03354988


Locations
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Egypt
Ain shams university hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: rania elfarrash, assprofessor Ain Shams univeristy
Additional Information:
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Responsible Party: Rania Ali El-Farrash, Associate Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT03354988    
Other Study ID Numbers: FMASU 2015
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases