WithdrawnNot Applicable

Impact of Exercise on Body Composition in Premature Infants

Stopped: Non applicable clinical trial

United States0Started 2011-06

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

Who can participate

Age range

29 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT01386190

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Body Composition, Beneficial trials