Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

March 19, 2019 updated by: Barbara Kozol, Asante Health System

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During fetal development the developing babe pushes against the uterine wall, often kicking and punching the unfortunate mother, especially during the last few months of pregnancy. The striking out against the resistance of the uterine wall causes joint compression in the arms, legs, and spine and that sensory feedback triggers bone growth. Unfortunately in the premature infant they are robbed of that exercise opportunity and are either splayed out in an incubator trying to copy with movement against gravity or swaddled so that movement isn't really an option. As a result bone density loss occurs in essentially all premature infants and osteopenia or significant loss can be an issue.

Between 1995 and 2008 there was a good deal of work done on identifying the importance of exercise and movement for premature infants. Moyer-Mileur was the leading researcher in the USA who demonstrated that simple exercise programs could prevent or decrease bone density loss. Although there is a shortage of trained therapists to provide these exercises safely they became a fairly common practice by 2010. At about that time the neonatologists at the Asante facility asked to incorporate the exercises into the NICU therapy program and after appropriate training the exercises began.

The Asante NICU is highly developmentally oriented. Infants grow 150 million brain cells an hour during the last few months of pregnancy. Any of the multiple stressors of prematurity can create cortisol and affect that brain growth. For that reason therapists became concerned with the joint compression exercises. While they were good for bone and muscle health the exercises were not always welcomed by the infant. Even the most gentle compassionate therapist is not always welcome if the infant just wants to sleep or be left alone. Therapists sought a system that could provide the needed exercise but in a manner more developmentally appropriate. It took two years of experimenting with different types of materials and different strengths of elasticity before the Prepod design finally evolved. Then the obvious hypothesis was - Will the Prepod be as effective in decreasing bone density loss as the traditional therapy exercises?? After multiple issues replacing originally planned DEXA measurements with safer UTS measurements, the first subjects were enrolled in 2013. Unfortunately in 2015 an issue with the ultrasound machine was identified; the anti-theft anklets the infants wore emitted signals that had corrupted the data. The study needed to be restarted in 2015, removing the anklets prior to measurement. It then proceeded without incident, with expected completion late 2018. At the IRB (Institutional Review Board) review winter of 2017 the overseeing group concluded that the data for length of stay was so compelling that continuing the study wasn't likely to change anything and basically amounted to withholding care from the traditional exercise infants. They ordered early closure of the study, despite the small number of study participants.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Medford, Oregon, United States, 97504
        • Rogue Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: 31 to 32 week gestation premature infants AGA (appropriate for gestational age weight) parental consent

Exclusion Criteria: Respiratory disease Low Apgars ( 5 minute less than 4) Syndromes affecting growth SGA (small for gestational age) medication requirements beyond vitamins, iron and caffeine

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prepod Group
Premature Infants (31 to 32 weeks gestation on entry to program), healthy who wear a prepod or elastic knit fabric pod with snaps essentially 24 hrs a day with brief breaks for bathing, exams, or parent skin to skin time. The intervention lasts 4 weeks
Other: Prepod
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.
Active Comparator: Control Group
Premature infants (31 to 32 weeks of age on entry to program), healthy who receive a joint compression exercise program approximately 10 minutes a day 5 days a week. The intervention lasts 4 weeks
Procedure: Joint compression exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone density
Time Frame: 27 to 28 days

Infants were divided into two groups - experimental (Prepod) and control (joint compression exercises).

The infants were measured at 31 to 32 weeks gestation using ultrasound to measure the SOS (speed of sound) through the left tibia at mid point between knee and ankle. They were then remeasured at end of study and the two measurements compared.
27 to 28 days
Change in length of Stay
Time Frame: 27 to 28 days
Infants in study were followed to discharge and length of stay from birth to discharge of the two matched groups were compared.
27 to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of length of stay of all Prepod candidates
Time Frame: 27 to 28 days
As mentioned in previous documentation the Prepod study began in 2013 but bone density data from 2013 to 2015 had to be discarded due to issues with UTS data corruption. However the infant experience in the Prepod and exercises were identical to those in the final study so length of stay of the combined population was examined.
27 to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asante Health System

Investigators

  • Principal Investigator: Barbara Kozol, MS,OTL, Barbara Kozol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2013

Primary Completion (Actual)

January 25, 2017

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanteHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Infant's names were coded on entry into all data tracking for privacy, HIPAA purposes. Individual data and results were not important (beyond assuring they maintained health) as the researcher was looking at overall trends

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prematurity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe