Assisted Exercise in Prematurity; Effects and Mechanisms

Not Applicable

Withdrawn

• Conditions: Development; Growth
• Interventions: Other: assisted exercise; Other: cuddle

• Registration Number: NCT00580099
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	assisted exercise	4 weeks of assisted exercise using passive range of motion on all major joints
2	cuddle	cuddle for 20 minutes

Primary Outcome Measures

Name	Time	Method
Body composition, bone mineralization, muscle mass, anthropometric measurements	4 weeks

Secondary Outcome Measures

Name	Time	Method
Blood Sampling to measure IGF-1, GHBP, IL-1ra	Baseline, week 2 and week 4
spontaneous movement	two time points
Neurological/behavioral status	end of 4th week

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Orange, California, United States