Assisted Exercise in Prematurity; Effects and Mechanisms | NCT00580099

Studies
Assisted Exercise in Prematurity; Effects and Mechanisms

NCT00580099

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Jan 25, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Growth
Development

Interventions

assisted exercise
cuddle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIH Grant R01NR009070

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Non applicable clinical trial

Expanded Access Info

Start Date

Feb 2006Actual

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
assisted exercise	Other	4 weeks of passive range of motion exercise	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body composition, bone mineralization, muscle mass, anthropometric measurements		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
spontaneous movement		two time points
Neurological/behavioral status		end of 4th week
Blood Sampling to measure IGF-1, GHBP, IL-1ra

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Weeks

Maximum Age

35 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dan M Cooper, MD	University of California, Irvine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine		Orange	California	92865	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19883474	Background	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.
17451077	Result	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications