Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
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
- 是
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 DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth.
Intervention
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
Ariel A. Salas
Principal Investigator
University of Alabama at Birmingham
