Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

NCT03884322 | Completed DMC

• 1 other identifier: AsanteHS
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; VLBW - Very Low Birth Weight Infant

Keywords

physical activity; prematurity; bone density; length of stay

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  27 to 28 days

Secondary Outcomes (1)

• Change of length of stay of all Prepod candidates

  27 to 28 days

Study Arms (2)

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

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

Procedure: Joint compression exercises

Interventions

Prepod OTHER

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.

Prepod Group

Joint compression exercises PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Asante Health System: lead

Study Sites (1)

Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Related Publications (9)

• 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.

  PMID: 18548083 BACKGROUND

• 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.

  PMID: 19707270 BACKGROUND

• 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.

  PMID: 7562289 BACKGROUND

• 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.

  PMID: 11061779 BACKGROUND

• 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.

  PMID: 18633420 BACKGROUND

• 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.

  PMID: 12837861 BACKGROUND

• 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.

  PMID: 27142078 BACKGROUND

• 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.

  PMID: 14647163 BACKGROUND

• 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.

  PMID: 23795735 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Motor Activity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Study Officials

• Barbara Kozol, MS,OTL

  Barbara Kozol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking not possible as obvious which child in pod. Infants were instead matched by age and weight to guarantee uniformity of sample
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Barbara Kozol,MS, OTL, staff neonatal occupational therapist

Model Details: 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

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 21, 2019
• Study Start: October 21, 2013
• Primary Completion: January 25, 2017
• Study Completion: March 30, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)