search
Back to results

Assisted Exercise in Prematurity; Effects and Mechanisms

Primary Purpose

Growth, Development

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
assisted exercise
cuddle
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Growth focused on measuring premature infant, body composition, total energy expenditure, inflammatory growth mediators

Eligibility Criteria

30 Weeks - 35 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

cuddle for 20 minutes

Outcomes

Primary Outcome Measures

Body composition, bone mineralization, muscle mass, anthropometric measurements

Secondary Outcome Measures

spontaneous movement
Neurological/behavioral status
Blood Sampling to measure IGF-1, GHBP, IL-1ra

Full Information

First Posted
December 18, 2007
Last Updated
January 22, 2021
Sponsor
University of California, Irvine
search

1. Study Identification

Unique Protocol Identification Number
NCT00580099
Brief Title
Assisted Exercise in Prematurity; Effects and Mechanisms
Official Title
Assisted Exercise in Prematurity; Effects and Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Non applicable clinical trial
Study Start Date
February 2006 (Actual)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth, Development
Keywords
premature infant, body composition, total energy expenditure, inflammatory growth mediators

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
4 weeks of assisted exercise using passive range of motion on all major joints
Arm Title
2
Arm Type
Active Comparator
Arm Description
cuddle for 20 minutes
Intervention Type
Other
Intervention Name(s)
assisted exercise
Intervention Description
4 weeks of passive range of motion exercise
Intervention Type
Other
Intervention Name(s)
cuddle
Intervention Description
cuddle infant for 20 minutes
Primary Outcome Measure Information:
Title
Body composition, bone mineralization, muscle mass, anthropometric measurements
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
spontaneous movement
Time Frame
two time points
Title
Neurological/behavioral status
Time Frame
end of 4th week
Title
Blood Sampling to measure IGF-1, GHBP, IL-1ra
Time Frame
Baseline, week 2 and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan M Cooper, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92865
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19883474
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.
Results Reference
background
PubMed Identifier
17451077
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.
Results Reference
result

Learn more about this trial

Assisted Exercise in Prematurity; Effects and Mechanisms

We'll reach out to this number within 24 hrs