Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/23/2019 |
| Start Date: | October 21, 2013 |
| End Date: | March 30, 2018 |
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.
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.
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.
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.
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
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