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临床试验/DRKS00022940
DRKS00022940已完成不适用

Postnatal head development of the preterm versus term infant head during the first year of life - a longitudinal observational study

Zentrum Zahn-, Mund- und Kieferheilkunde / Poliklinik für Kieferorthopädie0 个研究点目标入组 51 人开始时间: 2020年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
one 至 32 Pregnancy(—)
性别
All

入选标准

  • preterm group:
  • preterm infants with a birth weight of < 1500 g and / or a gestational age of < 32+0 weeks
  • term group:
  • term infants, that don't meet any exclusion criteria

排除标准

  • General exclusion criteria for study participation:
  • Palliative care
  • General exclusion criteria for the control group:
  • - Syndromal disease
  • - extensive head deformities
  • - Hydrocephalus
  • - Intraventricular hemorrhage
  • - Premature craniosynostosis of any kind
  • - Neurological or muscular disorder
  • - 5-minute-APGAR <7
  • - Development of a plagio- oder brachiocephalus during the study
  • - gestational age < 37 weeks
  • - Palliative care
  • Exclusion criteria for the single measurement for all patients:
  • - critical/deteriorating cllinical condition (i.e. severe sepsis, ECMO, PFC)
  • Criteria for study drop out of a single patient:
  • clinical deterioration without improvement
  • disclaim of parental consent
  • Criteria for termination of the study:
  • if there is evicence for risk to patient safety
  • if the study hypothesis is alreday answered after interim analysis

研究者

发起方
Zentrum Zahn-, Mund- und Kieferheilkunde / Poliklinik für Kieferorthopädie

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