Assisted Exercise in Prematurity; Effects and Mechanisms

Growth Clinical Trial

Official title:

Assisted Exercise in Prematurity; Effects and Mechanisms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580099
• Other study ID #: 2005-4797
• Secondary ID: NIH Grant R01NR0
• Status: Withdrawn
• Phase: N/A
• Start date: February 2006
• Est. completion date: February 2006

Study information

• Verified date: January 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Development
• Growth
• Premature Birth

Intervention

Other:
• assisted exercise
4 weeks of passive range of motion exercise
• cuddle
cuddle infant for 20 minutes

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition, bone mineralization, muscle mass, anthropometric measurements		4 weeks
Secondary	spontaneous movement		two time points
Secondary	Neurological/behavioral status		end of 4th week
Secondary	Blood Sampling to measure IGF-1, GHBP, IL-1ra		Baseline, week 2 and week 4