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Assisted Exercise in Prematurity; Effects and Mechanisms
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by University of California, Irvine.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of California, Irvine
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) |
| Official Title: | Assisted Exercise in Prematurity; Effects and Mechanisms |
Resource links provided by NLM:
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 ]
Secondary Outcome Measures:
- spontaneous movement [ Time Frame: two time points ]
- Neurological/behavioral status [ Time Frame: end of 4th week ]
- Blood Sampling to measure IGF-1, GHBP, IL-1ra [ Time Frame: Baseline, week 2 and week 4 ]
| 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) |
| 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
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
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 |
Keywords provided by University of California, Irvine:
|
premature infant, body composition, total energy expenditure inflammatory growth mediators |
ClinicalTrials.gov processed this record on June 22, 2017