Clinical trial NCT00580099: Assisted Exercise in Prematurity; Effects and Mechanisms
Official title: Assisted Exercise in Prematurity; Effects and Mechanisms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth
Development
Keywords: premature infant, body composition, total energy expenditure
inflammatory growth mediators
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Body composition, bone mineralization, muscle mass, anthropometric measurements
timeFrame: 4 weeks
Secondary outcomes:
measure: spontaneous movement
timeFrame: two time points
measure: Neurological/behavioral status
timeFrame: end of 4th week
measure: Blood Sampling to measure IGF-1, GHBP, IL-1ra
timeFrame: Baseline, week 2 and week 4
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Dan M Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.