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临床试验/NCT07051122
NCT07051122已完成不适用

Personalised Nutrition for the Preterm Infant

University College Cork1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Nutrient delivery

研究概览

简要总结

The aim of the Pinpoint observational study is to collect nutrition and health data in a cohort of preterm, low birth weight infants to investigate if their nutrition support is adequate. Results will inform nutritional requirements and monitoring of preterm infants for macronutrients and micronutrients.

详细描述

Background The goal of neonatal nutrition in the preterm infant is to achieve postnatal growth and body composition approximating that of a normal fetus of the same postmenstrual age and to obtain a functional outcome comparable to infants born at term. While international consensus guidelines for the nutritional management of preterm infants have been formulated, gaps between these nutrition guidelines and clinical practice have been extensively reported, resulting in nutritional deficits and inadequate growth and development.

A previous study of preterm infants (NCT01881256), showed that despite best practice guidelines, infants did not receive sufficient energy and protein to meet recommendations, which contributed to early growth failure. While some recent progress has been made in the field, with studies demonstrating reductions in cumulative nutrient deficits and improvements in growth after the optimisation of nutritional protocols, uncertainties still remain as to the nutritional requirements of preterm infants and how best to meet them. The nutritional management of preterm infants is complicated by their complex nutritional needs and different sources of nutrients as they progress through the neonatal course.

Challenge A major drawback is the lack of real-time feedback data on actual daily nutrient intakes of infants in the neonatal unit. Without this precise information, nutritional management is based on estimates, which can lead to nutritional deficits. The consequences of missed opportunities for optimal nutrient delivery may be far-reaching, in terms of inadequate growth and suboptimal developmental outcomes. Enhanced nutritional data collection and monitoring at the infant's cot-side in the neonatal unit would support more effective clinical decision-making, resulting in improved outcomes for infants.

Objective To collect extensive data on nutrition and health in preterm, low birth weight infants to inform development of bespoke software to track nutrient delivery in the neonatal unit. To describe relationships between nutrient delivery and nutritional status of iron and vitamin D and to analyse the impact of revised nutritional recommendations on nutrition and growth.

研究设计

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

入排标准

年龄范围
— 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age <34 weeks
  • Birth weight ≤1800g
  • Parents/legally authorised representative provides signed and dated informed proxy consent within 48 hours of infant's birth.

排除标准

  • Infants born with life-threatening congenital or chromosomal abnormalities.

结局指标

主要结局

Nutrient delivery

时间窗: From enrolment up to 10 weeks

Total energy, macronutrient and micronutrient delivery from all sources, including parenteral and enteral nutrition and nutritional supplements will be collected and analysed in MC Excel and our bespoke preterm nutrition software to calculate individual energy, macronutrient and micronutrient intakes (on a daily basis) for comparison with historical data and international recommendations.

次要结局

  • Infant weight(From enrolment to 6 months corrected age)
  • Infant length(From enrolment to 6 months corrected age)

研究者

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

Mairead Kiely PhD

Professor

University College Cork

研究点 (1)

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