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临床试验/NCT02833818
NCT02833818Unknown不适用

Growth and Development of Premature Babies

Elin Wahl Blakstad0 个研究点目标入组 200 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Growth at 4 months corrected months age

研究概览

简要总结

There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that can provide knowledge of growth and weight development in preterm and small for gestational age (SGA) infants with a birth weight between 1500 and 2000g.

详细描述

There has been little focus, at least there are few scientific reports on preterm infants with birth weights between 1500 and 2000g, at least in Norway. Studies have shown the benefit of enhanced protein and energy supplements in very low birth weight infants (VLBW, birth weight < 1500g), regarding growth and neurodevelopment . Adequate and properly balanced supply of nutrients is believed to give better growth and cognitive development in premature infants with slightly higher birth weight, i.e between 1500 and 2000g (1). In an intervention study of VLBW children at four Norwegian hospitals we found lower supply of energy and protein than international recommendations (2). A larger proportion of premature children were stunted growth (weight below 10 percentile for age) during hospitalization. Although this applies to preterm infants with birth weight less than 1500 g, this may also be the case for larger premature patients.

More studies that can provide knowledge of growth rate, weight and neurodevelopmental outcomes in preterm and small for gestational age (SGA) infants are warranted. This study examines those with birth weight between 1500 and 2000g. Overall, this may provide new and useful knowledge that can help to optimize the nutrition to preterm and SGA infants with a this range of birth weights

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
26 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Birth weight between 1500 and 2000g.
  • No invasive catheters or ventilator (wish homogeneous group).
  • No malformations or chromosomal disorders.
  • Parents give informed written consent
  • Born at study hospitals

排除标准

  • Birth weight below 1500 and above 2000g.
  • Invasive catheters or ventilator.
  • Malformations or chromosomal disorders.

结局指标

主要结局

Growth at 4 months corrected months age

时间窗: From birth until 4 months postmenstrual age (PMA)

Growth from birth, during hospital stay, at discharge/term and at 4 months PMA.

Breastfed, full or partly, and solid food at 4 months PMA

时间窗: From birth until 4 months PMA

Eating habits at discharge/term and at 4 months PMA .

次要结局

未报告次要终点

研究者

发起方
Elin Wahl Blakstad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elin Wahl Blakstad

dr. Elin Wahl Blakstad

University Hospital, Akershus

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