Body Composition, Beneficial Clinical Trial
Official title:
Impact of Exercise on Body Composition in Premature Infants: New Approaches
Verified date | January 2021 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: 1. Body composition 2. Associated biochemical and cellular mechanisms of growth and inflammation 3. Quality of maternal care will be measured
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 29 Weeks to 34 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine Douglas Hospital | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ages: 34-40 weeks gestational age and 86 - 92 weeks of age | |
Secondary | 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. | ages: 34-40 weeks gestational age and 86 - 92 weeks of age | |
Secondary | 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. | ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age | |
Secondary | 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 | age: 86-92 weeks | |
Secondary | 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. | ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age | |
Secondary | 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. | ages: 34-40 weeks gestational age and 86 to 92 weeks of age | |
Secondary | 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. | ages: 34-40 weeks gestational age and 86 to 92 weeks of age |
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