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Assisted Exercise in Prematurity; Effects and Mechanisms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580099
First received: December 18, 2007
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose
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 Intervention
Growth
Development
 Other: assisted exercise
Other: cuddle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Assisted Exercise in Prematurity; Effects and Mechanisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Body composition, bone mineralization, muscle mass, anthropometric measurements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spontaneous movement [ Time Frame: two time points ] [ Designated as safety issue: No ]
  • Neurological/behavioral status [ Time Frame: end of 4th week ] [ Designated as safety issue: No ]
  • Blood Sampling to measure IGF-1, GHBP, IL-1ra [ Time Frame: Baseline, week 2 and week 4 ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   30 Weeks to 35 Weeks   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: December 18, 2007
Last Updated: April 8, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 27, 2016