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

NCT03354988 | Unknown

• 1 other identifier: FMASU 2015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Osteopenia Prematurity

Outcome Measures

Primary Outcomes (6)

• serum calcium

  mg/dL

  2 weeks

• serum PO4

  mg/dL

  2 weeks

• serum magnesium

  mg/dL

  2 weeks

• ALP

  IU/L

  2 weeks

• CTX

  pg/mL

  2 weeks

• Whole body BMD

  mg/cm2

  2 weeks

Study Arms (2)

physical exercise group

ACTIVE COMPARATOR

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

Control group

OTHER

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

Interventions

Physical exercise group OTHER

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

physical exercise group

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• rania elfarrash, assprofessor

  Ain Shams univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: November 28, 2017
• Study Start: January 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)