Assisted Exercise in Prematurity; Effects and Mechanisms

Study Overview
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Brief Summary
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Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body composition and neurological/behavioral development of healthy growing premature infants enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets the exercise intervention and the control group is cuddled for the same amount of time -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth hormone. Video of each subject is recorded an hour at two time points during the study to assess the babies for spontaneous activity. Nutritional intake information is collected daily and in the 4th week of the study assessments made for total energy expenditure using doubly labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison. Finally in the period just before discharge we do a complex neurological exam using the Brazelton NBAS assessment.

Official Title
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Assisted Exercise in Prematurity; Effects and Mechanisms

Conditions
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Growth, Development

Intervention / Treatment
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* Other: assisted exercise
* Other: cuddle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born at post menstrual ages of 23-33 weeks gestation Enrollment occurs at post menstrual age of 30 to 35 weeks.if their projected stay based on standard clinical criteria is four weeks after enrollment Enrollment occurs at post menstrual age of 30 up to 35 weeks, if their projected stay based on standard clinical criteria is 4 weeks after enrollment. Birth weight appropriate for gestational age (AGA) using current CDC growth charts. AGA is defined as plus or minus 2 standard deviations above the mean or above the third percentile. Tolerating full enteral feeds at greater than or equal to 100kcal/kg/day Exclusion Criteria: Evidence of chromosomal or other major genetic abnormalities Existence of current diseases or syndromes including: central nervous system or other neurological abnormalities chronic lung disease of prematurity requiring chronic use of corticosteroids, musculoskeletal diseases positive infant toxicology screen(urine) for drugs or alcohol Both parents are under the age of 18 years Babies with tracheostomy Babies receiving ventilator assistance with breathing Babies receiving IV fluids

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 weeks of assisted exercise using passive range of motion on all major joints | Other: assisted exercise<br>* 4 weeks of passive range of motion exercise<br>|
| Active Comparator: 2<br>cuddle for 20 minutes | Other: cuddle<br>* cuddle infant for 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition, bone mineralization, muscle mass, anthropometric measurements |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous movement |  | two time points | 
| Neurological/behavioral status |  | end of 4th week | 
| Blood Sampling to measure IGF-1, GHBP, IL-1ra |  | Baseline, week 2 and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infant, body composition, total energy expenditure, inflammatory growth mediators