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Assisted Exercise in Prematurity; Effects and Mechanisms

NCT00580099 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-25

No results posted yet for this study

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

Interventions

OTHER

assisted exercise

4 weeks of passive range of motion exercise

OTHER

cuddle

cuddle infant for 20 minutes

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Dan M Cooper, MD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00580099 on ClinicalTrials.gov