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临床试验/NCT00382876
NCT00382876Unknown不适用

Identifying the Relative Change in Ventilation With Changes in Infant Sleeping Position

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1

研究概览

简要总结

The infant car restraint devices are a critical part of infant safety during transportation. The crash tolerance and the critical safety features of each seat are well established. Infant transportation may be via a car seat or car bed. The effect of the sitting position on the airway is a concern in an infant with poor head control. Because of this concern, car seat tests during which oxygen saturation is measured, are performed on many low birth weight infants before discharge from the nursery. Indeed, a number of deaths have occurred in car seats probably related to airway obstruction. The relative effects of position on the ventilation need to be established.

We propose to identify the relative changes in ventilation that are induced by position change during sleep. We will collect a broad array of high quality data that will identify these changes, and the most likely cause. Specifically, we will we screen 200 infants, with each infant assigned to the supine position, the car bed and the car seat. The order of these positions will be randomly assigned. Following data will be collected:

  1. Relative changes in ventilation will be assessed by oxygen saturation measurement.
  2. Respiratory movement will be measured in order to define the defect.
  3. Once the data is collected, it will be sent for blind data analysis.
  4. Once the data analysis is complete, the effect of position on ventilation will be established.

详细描述

BACKGROUND AND RATIONALE

The safe transportation of infants has formed a critical part of public health policy for many years. Clearly crash tolerance of the seat, the ease of installation, the position of the seat and the relative position to airbags has been the focus of intensive research. However as with all safety devices, there are some limitations. Respiratory instability is a potential concern due to the upright position in the car seat. This is particularly true in the premature newborn and has resulted in the recommendation to perform car safety seat testing before discharge from hospital for these infants.

Recently there have also been concerns raised about term infants. Merchant et al showed that mean oxygen saturations declined in both term and premature infants reaching a nadir of 95% after about 70 minutes of placement in a car safety seat with 8% noted to have an SaO2 of less than 90% for more than 20 minutes. Also, in an earlier study by Bass and Mehta, selected high risk full term infants were found to have increased risk of developing hypoxia.

It has been generally accepted that the potential for adverse effects from these hypoxic events are substantially offset by the crash protection afforded by these devices. Unfortunately, the portability of car seats and contemporary busy lifestyles are resulting in infants spending extended periods of time in the car seat for reasons other than transport. Callahan et al found in 187 infants that 94% spent greater than 30 minutes in seating devices including car seats each day. The mean time spent in seating devices was 5.7+/- 3.5 hours and ranged from 0 to 16 hours. Prolonged use of car seats in infants too young to sit unsupported may also potentially result in prolonged periods of oxygen desaturation.

A recent comprehensive review of peer reviewed published evidence noted that hypoxia has frequently been associated with significant defects in cognition. In some studies changes in cognitive function were seen with even mild levels of oxygen desaturation. Such changes were observed in all groups except premature babies. The young child may be relative resistant, as their physiology is adapted for the relatively hypoxic intrauterine environment. However a recent study also suggests that premature infants may also have problems. Thus a cautious approach has been adopted where children who fail to maintain adequate oxygen saturation while placed in the car seat are discharged in a car bed.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

年龄范围
1 Day 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Weight greater than 2.8 kg
  • Gestation 38-41 weeks
  • Normal newborn examinations
  • Healthy mother

排除标准

  • Weight greater than 4 kg
  • Any abnormality on examination
  • Any medications in mother and child (including insulin; vitamins and folic acid are okay).
  • Caesarean section

研究者

申办方类型
Other

研究点 (1)

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