Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
NCT ID: NCT03884322
Last Updated: 2019-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2013-10-21
2018-03-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
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.
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Exclusion Criteria
32 Weeks
36 Weeks
ALL
Yes
Sponsors
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Asante Health System
OTHER
Responsible Party
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Barbara Kozol
Barbara Kozol,MS, OTL, staff neonatal occupational therapist
Principal Investigators
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Barbara Kozol, MS,OTL
Role: PRINCIPAL_INVESTIGATOR
Barbara Kozol
Locations
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Rogue Regional Medical Center
Medford, Oregon, United States
Countries
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References
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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.
Hovi 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.
Moyer-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.
Moyer-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.
Vignochi 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.
Litmanovitz 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.
Litmanovitz 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.
Pereda 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.
Basu 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.
Other Identifiers
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AsanteHS
Identifier Type: -
Identifier Source: org_study_id
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