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临床试验/NCT06207071
NCT06207071招募中不适用

Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
152
试验地点
2
主要终点
Head circumference at 36 weeks postmenstrual age or discharge

研究概览

简要总结

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
24 Hours 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational ages between 22 0/7 - 32 6/7 weeks gestation
  • < 25th centile birthweight

排除标准

  • Major congenital/chromosomal anomalies
  • Terminal illness in which decisions to withhold or limit support have been made

研究组 & 干预措施

Control

No Intervention

No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.

Intervention

Active Comparator

A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.

干预措施: DHA (Dietary Supplement)

结局指标

主要结局

Head circumference at 36 weeks postmenstrual age or discharge

时间窗: Birth to 36 weeks postmenstrual age or discharge

Declines in head circumference z scores from birth to 36 weeks postmenstrual age

次要结局

  • Fat mass(FM)-for-age Z-score(Birth to 36 weeks postmenstrual age)
  • Changes in serum metabolic profile at 36 weeks postmenstrual age(36 weeks postmenstrual age or discharge)

研究者

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

Ariel A. Salas

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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