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临床试验/NCT04770636
NCT04770636Enrolling By Invitation不适用

Glucose Disturbances in the First Day of Life in Preterm Infants and Health-related Quality of Life: is There a Correlation?

Clinical Hospital Center Rijeka1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
Comparison of glucose levels in prematures after birth and Quality of life in the age of 7 years

研究概览

简要总结

The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years

详细描述

All premature infants treated from August 2013-August 2014 in two Neonatal intensive care units (NICUs) are included in this study. Glucose levels was analyzed two hours after birth. In the age of 8 months parents completed the questionnaire Pediatric Quality of Life - Infant scale. The questionnaire Quality of life for children 5-7 years and for their parents will be offered to them in the next 4 months.

We will investigate if there is a correlation between glucose levels and quality of life in premature infants, and if quality of life changes over years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All premature infants treated in two neonatal intensive units in Clinical Hospital centre Rijeka in the year 2013.-
  • To reach to final outcome, all questionnaires must be completed.

排除标准

  • All deceased premature children born in the study period.

结局指标

主要结局

Comparison of glucose levels in prematures after birth and Quality of life in the age of 7 years

时间窗: 7 years

Glucose level was measured two hours after birth in all premature infants. In the age of 8 months and 7 years Quality of life was measured using the questionnaire Paediatric Quality of Life (PedsQL) - Infant scale (6-12 months). The PedsQL Young Child report (5-7 years) and Parent report for Young children (5-7 years) will be offered to one parent/caregiver. In both scales minimum value is zero and maximum is 100; Higher score means better quality of life. The correlation between glucose levels in premature infants and quality of life will be investigated.

次要结局

  • Comparison of Quality of life in premature infants in the age of 8 months and 7 years(6,5 years)

研究者

发起方
Clinical Hospital Center Rijeka
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Lah Tomulić

MD, PhD

Clinical Hospital Center Rijeka

研究点 (1)

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