Impact of Exercise on Body Composition in Premature Infants

NCT01386190 | Withdrawn DMC

• 2 other identifiers: R01H110163-01A1 [2011-8156]HS # 2011-8156
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

1. 1.Body composition
2. 2.Associated biochemical and cellular mechanisms of growth and inflammation
3. 3.Quality of maternal care will be measured

Conditions

Body Composition, Beneficial

Keywords

preterm infant, body composition, exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Blood sample

  ages: 34-40 weeks gestational age and 86 - 92 weeks of age

• Energy Expenditure 1 Accelerometer three time points in the study

  ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age

• Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water

  age: 86-92 weeks

• Diet Assessments

  ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age

• Quality of Caregiver-Child Interaction

  ages: 34-40 weeks gestational age and 86 to 92 weeks of age

Study Arms (2)

Exercise Group

EXPERIMENTAL

Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age.

Other: Exercise/Social Behavioral

Control

ACTIVE COMPARATOR

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.

Other: Exercise/Social Behavioral

Interventions

Exercise/Social Behavioral OTHER

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.

Control; Exercise Group

Eligibility Criteria

• Age: 29 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Douglas Hospital

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Glucocorticoid Receptor Deficiency; Premature Birth; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dan M. Cooper, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)