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临床试验/NCT03884322
NCT03884322已完成不适用

Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

Asante Health System1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
Change in length of Stay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Masking not possible as obvious which child in pod. Infants were instead matched by age and weight to guarantee uniformity of sample

入排标准

年龄范围
32 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •31 to 32 week gestation premature infants AGA (appropriate for gestational age weight) parental consent

排除标准

  • •Respiratory disease Low Apgars ( 5 minute less than 4) Syndromes affecting growth SGA (small for gestational age) medication requirements beyond vitamins, iron and caffeine

研究组 & 干预措施

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

干预措施: Prepod (Other)

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

干预措施: Joint compression exercises (Procedure)

结局指标

主要结局

Change in length of Stay

时间窗: 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.

Change in bone density

时间窗: 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.

次要结局

  • Change of length of stay of all Prepod candidates(27 to 28 days)

研究者

发起方
Asante Health System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Kozol

Barbara Kozol,MS, OTL, staff neonatal occupational therapist

Asante Health System

研究点 (1)

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