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临床试验/NCT03635944
NCT03635944已完成不适用

Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.

Hôpital de la Croix-Rousse1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2016年12月1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
71
试验地点
1
主要终点
Weight gain during hospitalization

研究概览

简要总结

As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.

By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

详细描述

In a retrospective study, all ELBW infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two European units (Lyon, france, and Stockholm, Sweden). Parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.Growth assessment Postnatal growth was precisely evaluated and compared in the two groups of infants.

Body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. We calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, HC, and crown-to-heel length using Olsen's references. Intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. Extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks PCA. I

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Minute 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • birth weight under 1000 grams
  • gestational age (GA) between 23 and 28 weeks
  • born in 2012
  • admitted during the first 24 hours of life
  • stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.

排除标准

  • Neonates with congenital anomalies

结局指标

主要结局

Weight gain during hospitalization

时间窗: between birth and 40 weeks

difference in weight between birth and discharge

次要结局

  • Crown-heel length gain during hospitalization(between birth and 40 weeks)
  • Head circumference gain during hospitalization(between birth and 40 weeks)

研究者

发起方
Hôpital de la Croix-Rousse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-charles PICAUD, MD, PhD

professor of pediatrics

Hôpital de la Croix-Rousse

研究点 (1)

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