PrematurityNCT03884322
Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
A study testing Prepod and Joint compression exercises in people with Prematurity and VLBW - Very Low Birth Weight Infant, run by Asante Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity, VLBW - Very Low Birth Weight Infant
- What is being tested?
- Prepod and Joint compression exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2013to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
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
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Rogue Regional Medical Center
Medford, Oregon, 97504
About this study
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.
Read the 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.
- Conditions
- Prematurity, VLBW - Very Low Birth Weight Infant
- Being tested
- Prepod, Joint compression exercises
- Keywords
- physical activity, prematurity, bone density, length of stay
- Medical subject headings
- Premature Birth, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prepod Group | Experimental | 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 Receives: Other: Prepod |
| Control Group | Active comparator | 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 Receives: Procedure: Joint compression exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density
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.
Measured: 27 to 28 days
Change in length of Stay
Infants in study were followed to discharge and length of stay from birth to discharge of the two matched groups were compared.
Measured: 27 to 28 days
Secondary outcomes (1)
Change of length of stay of all Prepod candidates
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.
Measured: 27 to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start21 Oct 2013
- Primary completion25 Jan 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hypothesis: Premature infants placed in elastic fabric "pods" with opportunity to self initiate exercise pushing against fabric would maintain bone density as well as premature infants receiving traditional joint compression exercises by trained therapists
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asante Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kozol, Asante Health System
- Investigators
- Barbara Kozol, MS,OTL, Principal investigator, Barbara Kozol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884322
- Sponsor's protocol ID
- AsanteHS
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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
Publications
Chan GM, Armstrong C, Moyer-Mileur L, Hoff C. Growth and bone mineralization in children born prematurely. J Perinatol. 2008 Sep;28(9):619-23. doi: 10.1038/jp.2008.59. Epub 2008 Jun 12.
PubMed 18548083Hovi P, Andersson S, Jarvenpaa AL, Eriksson JG, Strang-Karlsson S, Kajantie E, Makitie O. Decreased bone mineral density in adults born with very low birth weight: a cohort study. PLoS Med. 2009 Aug;6(8):e1000135. doi: 10.1371/journal.pmed.1000135. Epub 2009 Aug 25.
PubMed 19707270Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.
PubMed 7562289Moyer-Mileur LJ, Brunstetter V, McNaught TP, Gill G, Chan GM. Daily physical activity program increases bone mineralization and growth in preterm very low birth weight infants. Pediatrics. 2000 Nov;106(5):1088-92. doi: 10.1542/peds.106.5.1088.
PubMed 11061779Vignochi CM, Miura E, Canani LH. Effects of motor physical therapy on bone mineralization in premature infants: a randomized controlled study. J Perinatol. 2008 Sep;28(9):624-31. doi: 10.1038/jp.2008.60. Epub 2008 Jul 17.
PubMed 18633420Litmanovitz I, Dolfin T, Friedland O, Arnon S, Regev R, Shainkin-Kestenbaum R, Lis M, Eliakim A. Early physical activity intervention prevents decrease of bone strength in very low birth weight infants. Pediatrics. 2003 Jul;112(1 Pt 1):15-9. doi: 10.1542/peds.112.1.15.
PubMed 12837861Litmanovitz I, Erez H, Eliakim A, Bauer-Rusek S, Arnon S, Regev RH, Sirota G, Nemet D. The Effect of Assisted Exercise Frequency on Bone Strength in Very Low Birth Weight Preterm Infants: A Randomized Control Trial. Calcif Tissue Int. 2016 Sep;99(3):237-42. doi: 10.1007/s00223-016-0145-3. Epub 2016 May 3.
PubMed 27142078Pereda L, Ashmeade T, Zaritt J, Carver JD. The use of quantitative ultrasound in assessing bone status in newborn preterm infants. J Perinatol. 2003 Dec;23(8):655-9. doi: 10.1038/sj.jp.7211006.
PubMed 14647163Basu M, Malhotra AS, Pal K, Chatterjee T, Ghosh D, Haldar K, Verma SK, Kumar S, Sharma YK, Sawhney RC. Determination of bone mass using multisite quantitative ultrasound and biochemical markers of bone turnover during residency at extreme altitude: a longitudinal study. High Alt Med Biol. 2013 Jun;14(2):150-4. doi: 10.1089/ham.2012.1042.
PubMed 23795735
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
- ClinicalTrials.gov ID
- NCT03884322
- Acronym / sponsor ID
- AsanteHS
- Conditions
- Prematurity, VLBW - Very Low Birth Weight Infant
- Keywords
- physical activity, prematurity, bone density, length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Asante Health SystemUniversity, hospital or other
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypothesis: Premature infants placed in elastic fabric "pods" with opportunity to self initiate exercise pushing against fabric would maintain bone density as well as premature infants receiving traditional joint compression exercises by trained therapists
| Arm | Type | Receives |
|---|---|---|
| Prepod Group | Experimental | Other: PrepodPremature 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 |
| Control Group | Active comparator | Procedure: Joint compression exercisesPremature 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 |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepodthe 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. | Other | Prepod Group |
| Joint compression exercisesEach 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. | Procedure or surgery | Control Group |
Primary outcome
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.
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.
1 secondary outcome
Change of length of stay of all Prepod candidates
Time frame: 27 to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 18548083Chan GM, Armstrong C, Moyer-Mileur L, Hoff C. Growth and bone mineralization in children born prematurely. J Perinatol. 2008 Sep;28(9):619-23. doi: 10.1038/jp.2008.59. Epub 2008 Jun 12.
- Background: PubMed 19707270Hovi P, Andersson S, Jarvenpaa AL, Eriksson JG, Strang-Karlsson S, Kajantie E, Makitie O. Decreased bone mineral density in adults born with very low birth weight: a cohort study. PLoS Med. 2009 Aug;6(8):e1000135. doi: 10.1371/journal.pmed.1000135. Epub 2009 Aug 25.
- Background: PubMed 7562289Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.
- Background: PubMed 11061779Moyer-Mileur LJ, Brunstetter V, McNaught TP, Gill G, Chan GM. Daily physical activity program increases bone mineralization and growth in preterm very low birth weight infants. Pediatrics. 2000 Nov;106(5):1088-92. doi: 10.1542/peds.106.5.1088.
- Background: PubMed 18633420Vignochi CM, Miura E, Canani LH. Effects of motor physical therapy on bone mineralization in premature infants: a randomized controlled study. J Perinatol. 2008 Sep;28(9):624-31. doi: 10.1038/jp.2008.60. Epub 2008 Jul 17.
- Background: PubMed 12837861Litmanovitz I, Dolfin T, Friedland O, Arnon S, Regev R, Shainkin-Kestenbaum R, Lis M, Eliakim A. Early physical activity intervention prevents decrease of bone strength in very low birth weight infants. Pediatrics. 2003 Jul;112(1 Pt 1):15-9. doi: 10.1542/peds.112.1.15.
- Background: PubMed 27142078Litmanovitz I, Erez H, Eliakim A, Bauer-Rusek S, Arnon S, Regev RH, Sirota G, Nemet D. The Effect of Assisted Exercise Frequency on Bone Strength in Very Low Birth Weight Preterm Infants: A Randomized Control Trial. Calcif Tissue Int. 2016 Sep;99(3):237-42. doi: 10.1007/s00223-016-0145-3. Epub 2016 May 3.
- Background: PubMed 14647163Pereda L, Ashmeade T, Zaritt J, Carver JD. The use of quantitative ultrasound in assessing bone status in newborn preterm infants. J Perinatol. 2003 Dec;23(8):655-9. doi: 10.1038/sj.jp.7211006.
- Background: PubMed 23795735Basu M, Malhotra AS, Pal K, Chatterjee T, Ghosh D, Haldar K, Verma SK, Kumar S, Sharma YK, Sawhney RC. Determination of bone mass using multisite quantitative ultrasound and biochemical markers of bone turnover during residency at extreme altitude: a longitudinal study. High Alt Med Biol. 2013 Jun;14(2):150-4. doi: 10.1089/ham.2012.1042.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Kozol, MS,OTL principal investigator
Barbara Kozol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepod and Joint compression exercises in people with Prematurity and VLBW - Very Low Birth Weight Infant, run by Asante Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone density (time frame: 27 to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884322, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.