Assisted Exercise in Prematurity; Effects and Mechanisms
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ClinicalTrials.gov Identifier: NCT00580099 |
Recruitment Status :
Withdrawn
(Non applicable clinical trial)
First Posted : December 24, 2007
Last Update Posted : January 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Growth Development | Other: assisted exercise Other: cuddle | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Assisted Exercise in Prematurity; Effects and Mechanisms |
Actual Study Start Date : | February 2006 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |

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 |
- Body composition, bone mineralization, muscle mass, anthropometric measurements [ Time Frame: 4 weeks ]
- 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 ]

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

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
United States, California | |
University of California, Irvine | |
Orange, California, United States, 92865 |
Principal Investigator: | Dan M Cooper, MD | University of California, Irvine |
Other Publications:
Responsible Party: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00580099 |
Other Study ID Numbers: |
2005-4797 NIH Grant R01NR009070 |
First Posted: | December 24, 2007 Key Record Dates |
Last Update Posted: | January 25, 2021 |
Last Verified: | January 2021 |
premature infant, body composition, total energy expenditure inflammatory growth mediators |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |