NCT00580099

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

December 18, 2007

Last Update Submit

January 22, 2021

Conditions

GrowthDevelopment

Keywords

premature infant, body composition, total energy expenditureinflammatory growth mediators

Outcome Measures

Primary Outcomes (1)

  • Body composition, bone mineralization, muscle mass, anthropometric measurements

    4 weeks

Secondary Outcomes (3)

  • spontaneous movement

    two time points

  • Neurological/behavioral status

    end of 4th week

  • Blood Sampling to measure IGF-1, GHBP, IL-1ra

    Baseline, week 2 and week 4

Study Arms (2)

1

EXPERIMENTAL

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

Other: assisted exercise

2

ACTIVE COMPARATOR

cuddle for 20 minutes

Other: cuddle

Interventions

assisted exerciseOTHER

4 weeks of passive range of motion exercise

1
cuddleOTHER

cuddle infant for 20 minutes

2

Eligibility Criteria

Age30 Weeks - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine

Orange, California, 92865, United States

Location

Related Publications (2)

  • 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.

    PMID: 19883474BACKGROUND

  • 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.

    PMID: 17451077RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dan M Cooper, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 24, 2007

Study Start

February 1, 2006

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

US(1)