Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
Condition: Prematurity; VLBW - Very Low Birth Weight Infant
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional

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.
    

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.
    

Intervention name(s): Prepod; Joint compression exercises
Intervention type(s): Other; Procedure
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Other
Keywords: physical activity; prematurity; bone density; length of stay