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Assisted Exercise in Prematurity; Effects and Mechanisms

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ClinicalTrials.gov Identifier: NCT00580099
Recruitment Status : Unknown
Verified April 2011 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : December 24, 2007
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:
University of California, Irvine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Development Other: assisted exercise Other: cuddle Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Assisted Exercise in Prematurity; Effects and Mechanisms
Study Start Date : September 2005
Actual Primary Completion Date : March 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
4 weeks of assisted exercise using passive range of motion on all major joints
 Other: assisted exercise
4 weeks of passive range of motion exercise
Active Comparator: 2
cuddle for 20 minutes
 Other: cuddle
cuddle infant for 20 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Body composition, bone mineralization, muscle mass, anthropometric measurements [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. spontaneous movement [ Time Frame: two time points ]
  2. Neurological/behavioral status [ Time Frame: end of 4th week ]
  3. Blood Sampling to measure IGF-1, GHBP, IL-1ra [ Time Frame: Baseline, week 2 and week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT00580099


Contacts
Contact: Julia K Rich, RN 714-456-2946 jkrich@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92865
Principal Investigator: Dan M Cooper, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Dan M Cooper, MD University of California, Irvine
More Information
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Publications of Results:

Other Publications:

Responsible Party: Dan M. Cooper MD, University of California Irvine
ClinicalTrials.gov Identifier: NCT00580099     History of Changes
Other Study ID Numbers: 2005-4797
NIH Grant R01NR009070
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

Keywords provided by University of California, Irvine:
premature infant, body composition, total energy expenditure
inflammatory growth mediators