Status:
UNKNOWN
Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
Lead Sponsor:
Ain Shams University
Conditions:
Osteopenia Prematurity
Eligibility:
All Genders
1-28 years
Phase:
NA
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 t...
Detailed Description
This is a prospective randomized controlled clinical trial that will be conducted on 36 VLBW preterm infants admitted to the neonatal intensive care unit (NICU) - Ain Shams University METHODS: All t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03354988
Start Date
January 1 2015
End Date
August 1 2018
Last Update
May 11 2018
Active Locations (1)
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1
Ain shams university hospital
Cairo, Egypt