Assisted Exercise in Prematurity; Effects and Mechanisms

NCT ID: NCT00580099

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-02-28

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.

Conditions

Growth; Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

1

4 weeks of assisted exercise using passive range of motion on all major joints

Group Type: EXPERIMENTAL

assisted exercise

Intervention Type: OTHER

4 weeks of passive range of motion exercise

2

cuddle for 20 minutes

Group Type: ACTIVE_COMPARATOR

cuddle

Intervention Type: OTHER

cuddle infant for 20 minutes

Interventions

assisted exercise

4 weeks of passive range of motion exercise

Intervention Type: OTHER

cuddle

cuddle infant for 20 minutes

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan M Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Orange, California, United States

Countries

United States

References

Gravem D, Lakes KD, Teran L, Rich J, Cooper D, Olshansky E. Maternal perceptions of infant exercise in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2009 Sep-Oct;38(5):527-33. doi: 10.1111/j.1552-6909.2009.01055.x.

Reference Type: BACKGROUND

PMID: 19883474 (View on PubMed)

Ahmad I, Zaldivar F, Iwanaga K, Koeppel R, Grochow D, Nemet D, Waffarn F, Eliakim A, Leu SY, Cooper DM. Inflammatory and growth mediators in growing preterm infants. J Pediatr Endocrinol Metab. 2007 Mar;20(3):387-96. doi: 10.1515/jpem.2007.20.3.387.

Reference Type: RESULT

PMID: 17451077 (View on PubMed)

Other Identifiers

NIH Grant R01NR009070

Identifier Type: -

Identifier Source: secondary_id

2005-4797

Identifier Type: -

Identifier Source: org_study_id