CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Prepod +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03884322
NCT03884322N/ACompleted

Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

Asante Health System·interventional·Posted Mar 21, 2019·Updated Mar 21, 2019

In Brief

A clinical study evaluating Prepod and Joint compression exercises for Prematurity and VLBW - Very Low Birth Weight Infant. Completed, enrolled 54 participants across 1 site.

Detailed Summary

Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss. Exercises lasted approximately 10 minutes each day 5 days a week. The experimental group were placed in a "prepod", an elastic fabric pod shaped garment or sack on entry into the study and remained in the pod essentially 24 hours a day, with brief breaks for bathing, parental skin to skin experiences,etc. An ultrasound of the left tibia was done on entrance into the study at 31 to 32 weeks gestation and again at completion of the study 4 weeks later. Results showed that experimental infants in pods had slightly less bone density loss than their peers receiving traditional therapy. An incidental finding was that the experimental infants in pods had a significantly shorter length of stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartOct 21, 2013
Primary CompletionJan 25, 2017
Study CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.3 years ago

Interventions

Prepodother

the prepod is either a 4 way stretch polyester blend fleece with 8 to 10% lycra, or a 95%cotton5% lycra blend knit. It comes in 4 different sizes to assure a pod that has a conforming but not restricting fit so that the infant is free to stretch in any direction at any time but is loosely held in a position of physiological flexion (the fetal position) when not stretching.

Joint compression exercisesprocedure

Each premature infant enrolled as a control subject received approximately 10 minutes of joint compression exercises provided by a NICU trained physical or occupational therapist 5x a week. The exercises consisted of waking the infant slowly, gently if necessary just before feeding with a simple range of motion stretching program then stabilizing an extremity and applying force distally to proximally for 6 repetitions with a brief pause between each compression.