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临床试验/NCT00408746
NCT00408746Unknown不适用

Prospective (Multicentre) Epidemiologic Longitudinal Study of Orofacial Development of Preterm and Low Birthweight Infants Compared to Term Infants in Consideration of Perinatal, Biometrical, Nutritional, Functional and Parental Parameters

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1

研究概览

简要总结

Preterm infants account for 6 % of all live-births in western societies. Scientific evidence can be found for altered palatal morphology in the short term among preterm children. Oral intubation and orogastric feeding might be contributing factors to these alterations, but it has not been examined whether in the absence of these interventions preterm infants' palates are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due to immaturity of oral function. Because of contradictory results, lack of longitudinal and high quality standard studies, the scientific evidence is also to weak to answer the question whether premature birth without or with a history of orotracheal intubation and orogastric feeding causes permanent alteration of orofacial development. The aim of the present study, therefore is to investigate in consideration of perinatal, biometrical, nutritional, functional and parental parameters.

详细描述

Preterm infants account for 6 % of all live-births in western societies. Scientific evidence can be found for altered palatal morphology in the short term among preterm children. Oral intubation and orogastric feeding might be contributing factors to these alterations, but it has not been examined whether in the absence of these interventions preterm infants' palates are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due to immaturity of oral function. Because of contradictory results, lack of longitudinal and high quality standard studies, the scientific evidence is also to weak to answer the question whether premature birth without or with a history of orotracheal intubation and orogastric feeding causes permanent alteration of orofacial development.

The aim of the present study, therefore is to investigate in consideration of perinatal, biometrical, nutritional, functional and parental parameters

  • whether preterm babies without a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to term babies.
  • in a second step whether preterm babies with a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to preterm and term infants without these interventions.

The participants must meet the following inclusion criteria:

all:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • infants of the tertiary care level University Hospital of Münster
  • delivery between May 1999 and December 2008
  • caucasian origin
  • written informed consent by both parents

排除标准

  • history of orotracheal intubation / orogastric tube feeding
  • hydrocephalus
  • palatal cleft, congenital syndrome, head / neck malformation
  • congenital metabolic disease beyond osteopenia of prematurity

研究者

发起方
University Hospital Muenster
申办方类型
Other

研究点 (1)

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