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临床试验/NCT07652684
NCT07652684招募中4 期

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年3月4日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
74
试验地点
1

研究概览

简要总结

The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).

详细描述

The intervention group will receive enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, while the control group will receive standard care and feeding. The intervention will commence within the first three days of life and will continue until 36 weeks postmenstrual age for both groups.

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
Single (Participant)

盲法说明

The statistician will also be masked.

入排标准

年龄范围
24 Weeks 至 29 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.

排除标准

  • Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.
  • Study participation requires written informed parental consent within 48h after birth.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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