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临床试验/NCT01683812
NCT01683812已完成不适用

Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants

Boston Children's Hospital4 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
4
主要终点
Feasibility and Safety

研究概览

简要总结

The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.

详细描述

The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows with the infant and maintains proper body alignment while promoting normal head shape development. While the cranial cup is not yet FDA approved, it is considered a non-significant medical device and it has successfully corrected asymmetric positional head shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis of a prospective randomized controlled trial currently underway suggests that the cranial cup may be useful in prevention of positional head shape deformity in a cohort of hospitalized infants of varying gestational ages. However, the cranial cup has never been used for correction of the most common form of positional head shape deformity in hospitalized premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to provide information on the feasibility of using the cranial cup in a small sample of prematurely born infants with dolichocephaly during the convalescent phase of their hospitalizations. Information obtained from this descriptive study will be used to determine if a larger investigation using the cranial cup is warranted in this specific patient population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Born at < or equal to 35 weeks gestation
  • Cleared for participation by healthcare team
  • Estimated minimum length of stay >14 days
  • Weight >1000 grams (at enrollment)
  • Dolichocephalic head shape deformity

排除标准

  • Unable to maintain airway patency (anatomical problem)
  • Craniofacial anomaly or scalp device, drain or shunt
  • Craniosynostosis
  • Severe parturitional head shape deformity

结局指标

主要结局

Feasibility and Safety

时间窗: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days

Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of \< 90 percent for infant corrected to full term or \< 87 percent for a premature infant for \> 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.

次要结局

  • Cranial Measurement Description(Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele DeGrazia

Director of Nursing Research NICU

Boston Children's Hospital

研究点 (4)

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