Impact of Exercise on Body Composition in Premature Infants
Primary Purpose
Body Composition, Beneficial
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise/Social Behavioral
Sponsored by

About this trial
This is an interventional prevention trial for Body Composition, Beneficial focused on measuring preterm infant, body composition, exercise
Eligibility Criteria
Infant Inclusion criteria:
- Infant is a healthy, growing NICU inpatient.
- Caregiver ≥18 years of age
- Infant gestational age at birth <29weeks
- Infant gestational age at time of study recruitment >34 wks, on full feeds and nearing discharge
Infant Exclusion criteria:
- Significant lung disease of prematurity requiring supplemental oxygen or corticosteroids at discharge
- Significant intraventricular hemorrhage, grade III -IV
- Necrotizing entrocolitis
- Tracheostomy
Bone Diseases
- Osteogenesis Imperfecta
- Hip or knee joint anomalies
- Arthrogryposis
- Fractures
- Skin disorders (e.g., Erythematus Bullosis)
- Symptomatic congestive heart disease
- Any other conditions or congenital anomalies likely to severely impact the ability of the premature baby and caregiver to participate in a demanding study
Sites / Locations
- University of California, Irvine Douglas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Group
Control
Arm Description
Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age.
Both the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
Outcomes
Primary Outcome Measures
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
LBM (lean body mass) will be measured and compared at the UCI Institute for Clinical and Translational Science. Dual X-ray Absorbiometry (DXA) scan to measure lean mass will be done using a whole body fan-beam scanner (Hologic QDR Discovery-A Hologic Inc., Bedford MA)at age 34-40 weeks gestational age and again at 86-92 weeks of age
Secondary Outcome Measures
Blood sample
Blood sample (IGF-I)insulin-like growth factor-I , (GHBP)growth hormone binding protein, (IL-1ra)interleukin-1 receptor antagonist,(IL-6)interleukin-6, (EPCs)Epithelial Progenitor Cells. Inflammatory/Stress and growth factors will be measured from infant blood. A blood sample will be obtained from the NICU before discharge. A second blood sample will be obtained (venous) from the infant at 1 year.The Enzyme-linked immunosorbent assay (ELISAs) for IGF-I, IL-6, GHBP, and IL-1ra are available and routinely performed in our laboratory.
Energy Expenditure 1 Accelerometer three time points in the study
Accelerometers provide robust, high fidelity logging of observed limb acceleration. The devices are worn in a canonical and identical orientation relative to the anatomy of each infant. Sleep/wake cycles of the babies will be synchronized to assure that comparable activity.
Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water
A study a subset of 100 of our enrollees will have total energy expenditure assessed by DLW. DLW measurements in children will be sent to our subcontract William Wong at Baylor University
Diet Assessments
Parents will be called at two random days during the week of the assessment, thereby making sure that the recall interviews capture 1 weekday and 1 weekend day. Information on infant nutrition will also be obtained by three 24-h dietary recall interviews with the primary caregiver. Each interview will take approximately 20-30 minutes.
Quality of Caregiver-Child Interaction
A standardized laboratory protocol developed for the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development and used currently by our group of researchers will be administered to determine quality of maternal infant interaction. For this protocol, observations are made during semi-structured play.
TIMP/AIMS
TIMP(Test of Infant Motor Performance)/AIMS(Alberta Infant Motor Scale) The AIMS (Alberta Infant Motor Scale) is a reliable norm-referenced observational motor assessment. The AIMS measures qualitative aspects of movement and it is sensitive to changes in infant's motor performance. We also plan a test of motor development (TIMP, Test of Infant Motor Performance) that was developed specifically for newborns, overlaps well with the AIMS, and can be used to guide our exercise intervention in the first months of life.
Full Information
NCT ID
NCT01386190
First Posted
June 21, 2011
Last Updated
January 22, 2021
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01386190
Brief Title
Impact of Exercise on Body Composition in Premature Infants
Official Title
Impact of Exercise on Body Composition in Premature Infants: New Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Non applicable clinical trial
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (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
This research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on:
Body composition
Associated biochemical and cellular mechanisms of growth and inflammation
Quality of maternal care will be measured
Detailed Description
Premature birth is recognized as the single most important health problem in maternal child health in the US. Paradoxically, both failure to thrive and obesity are now known to be associated with prematurity, as are osteopenia (a condition where bone mineral density is lower than normal) and increased risk of fracture, and increased risk of cardiovascular disease later in life. We lack cohesive approaches to mitigate these profound threats to health. Despite promising new research demonstrating that physical activity can stimulate the growth of muscle and bone even during intrauterine life (perhaps through metabolic programming), there have been very few attempts to implement and study physical activity interventions in the premature baby.
The challenges are substantial and include:
measuring body composition
assessing physical activity
engaging caregivers as partners in the intervention
identifying plausible and testable biological mechanisms
designing interventions that actually increase physical activity and match the rapid pace of motor development early in life
A developmentally dynamic physical activity intervention has been designed and pilot tested-one that engages the caregiver as a partner. Using techniques and tools as far-ranging as Dual X-ray Absorbiometry (DXA), smart phones, doubly labeled water, and lightweight, wireless accelerometers developed specifically for this purpose, the working hypothesis is that the one-year intervention will augment lean body mass (primary outcome variable) and improve bone mineralization and the ratio of lean to fat tissue (secondary outcome variables). The study will gauge the impact of the physical activity intervention on the balance between circulating anabolic mediators (insulin-like growth factor-I and growth hormone binding protein) and inflammation-associated cytokines (interleukin-6, and interleukin-1 receptor antagonist), which antagonize muscle and bone growth.
We will additionally:
begin to explore how physical activity influences circulating endothelial progenitor cells, which are increasingly viewed as markers of vascular health very early in life
take advantage of this prospective, interventional study to explore potential genetic determinants of growth in babies born prematurely.
Finally, any study involving the premature infant and the data associated with it must be viewed in light of the critical relationship between the mother and baby.
The potential broad impact of early life interventions has been recently demonstrated by the success of the "Back-To-Sleep" campaign in mitigating sudden infant death syndrome. Should the positive effects of augmented exercise on body composition be supported, we would then anticipate widespread benefit in preventing long-term health consequences of prematurity at relatively low cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Composition, Beneficial
Keywords
preterm infant, body composition, exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Both the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
Intervention Type
Other
Intervention Name(s)
Exercise/Social Behavioral
Intervention Description
Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
Primary Outcome Measure Information:
Title
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
Description
LBM (lean body mass) will be measured and compared at the UCI Institute for Clinical and Translational Science. Dual X-ray Absorbiometry (DXA) scan to measure lean mass will be done using a whole body fan-beam scanner (Hologic QDR Discovery-A Hologic Inc., Bedford MA)at age 34-40 weeks gestational age and again at 86-92 weeks of age
Time Frame
ages: 34-40 weeks gestational age and 86 - 92 weeks of age
Secondary Outcome Measure Information:
Title
Blood sample
Description
Blood sample (IGF-I)insulin-like growth factor-I , (GHBP)growth hormone binding protein, (IL-1ra)interleukin-1 receptor antagonist,(IL-6)interleukin-6, (EPCs)Epithelial Progenitor Cells. Inflammatory/Stress and growth factors will be measured from infant blood. A blood sample will be obtained from the NICU before discharge. A second blood sample will be obtained (venous) from the infant at 1 year.The Enzyme-linked immunosorbent assay (ELISAs) for IGF-I, IL-6, GHBP, and IL-1ra are available and routinely performed in our laboratory.
Time Frame
ages: 34-40 weeks gestational age and 86 - 92 weeks of age
Title
Energy Expenditure 1 Accelerometer three time points in the study
Description
Accelerometers provide robust, high fidelity logging of observed limb acceleration. The devices are worn in a canonical and identical orientation relative to the anatomy of each infant. Sleep/wake cycles of the babies will be synchronized to assure that comparable activity.
Time Frame
ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Title
Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water
Description
A study a subset of 100 of our enrollees will have total energy expenditure assessed by DLW. DLW measurements in children will be sent to our subcontract William Wong at Baylor University
Time Frame
age: 86-92 weeks
Title
Diet Assessments
Description
Parents will be called at two random days during the week of the assessment, thereby making sure that the recall interviews capture 1 weekday and 1 weekend day. Information on infant nutrition will also be obtained by three 24-h dietary recall interviews with the primary caregiver. Each interview will take approximately 20-30 minutes.
Time Frame
ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Title
Quality of Caregiver-Child Interaction
Description
A standardized laboratory protocol developed for the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development and used currently by our group of researchers will be administered to determine quality of maternal infant interaction. For this protocol, observations are made during semi-structured play.
Time Frame
ages: 34-40 weeks gestational age and 86 to 92 weeks of age
Title
TIMP/AIMS
Description
TIMP(Test of Infant Motor Performance)/AIMS(Alberta Infant Motor Scale) The AIMS (Alberta Infant Motor Scale) is a reliable norm-referenced observational motor assessment. The AIMS measures qualitative aspects of movement and it is sensitive to changes in infant's motor performance. We also plan a test of motor development (TIMP, Test of Infant Motor Performance) that was developed specifically for newborns, overlaps well with the AIMS, and can be used to guide our exercise intervention in the first months of life.
Time Frame
ages: 34-40 weeks gestational age and 86 to 92 weeks of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Infant Inclusion criteria:
Infant is a healthy, growing NICU inpatient.
Caregiver ≥18 years of age
Infant gestational age at birth <29weeks
Infant gestational age at time of study recruitment >34 wks, on full feeds and nearing discharge
Infant Exclusion criteria:
Significant lung disease of prematurity requiring supplemental oxygen or corticosteroids at discharge
Significant intraventricular hemorrhage, grade III -IV
Necrotizing entrocolitis
Tracheostomy
Bone Diseases
Osteogenesis Imperfecta
Hip or knee joint anomalies
Arthrogryposis
Fractures
Skin disorders (e.g., Erythematus Bullosis)
Symptomatic congestive heart disease
Any other conditions or congenital anomalies likely to severely impact the ability of the premature baby and caregiver to participate in a demanding study
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 Douglas Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Exercise on Body Composition in Premature Infants
We'll reach out to this number within 24 hrs