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临床试验/NCT01982422
NCT01982422已完成不适用

Developmental Origins of Attention Deficit Hyperactivity Disorder

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Functional neuroconnectivity of neonate assessed by MRI

研究概览

简要总结

This is a study evaluating the relationship between prenatal nutrition and neural development in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd trimester of pregnancy will have infants with more advanced neural development as compared to infants born to mothers receiving standard-of-care treatment.

详细描述

Pregnant women with ADHD will be recruited from the patient population at Oregon Health & Science University (OHSU). They will be recruited during their 1st or 2nd trimester. After consent, baseline measures will be collected including height, weight, body composition measurements using calipers, 24-hour dietary recalls, and blood and urine samples. Women will also complete questionnaires regarding ADHD symptoms, stress, depression, and lifestyle. Women will be given a one-week food diary to fill out at home, which will be mailed in upon completion. Upon receipt of the food diary, women will be randomized into either a nutrition intervention group or a standard-of-care group. Women who are randomized to the intervention group will receive individual nutritional counseling every 2 weeks during their 3rd trimester of pregnancy. Before delivery, the baseline measures described above will again be collected. At delivery, placenta and cord blood samples will be taken. After birth, the infant will undergo an MRI between 2 and 5 weeks of age. The scan is completed while the baby sleeps, and special ear protection is worn to limit sleep disruption from the noise of the MRI. When the infant is 3 months old, mothers will complete questionnaires about infant feeding, sleep and behavior.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in general good health
  • 18 years of age or older
  • Confirmed pregnancy and currently between 8 and 24 weeks pregnant
  • With symptoms of inattention or impulsivity

排除标准

  • Obstetrician confirmed high-risk pregnancy
  • Current drug/alcohol addiction
  • Current smoker
  • Unwilling/unable to discontinue psychiatric medication during pregnancy
  • Comorbid schizophrenia, bipolar, or major depressive disorder

研究组 & 干预措施

Dietary Intervention

Experimental

A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.

干预措施: Whole Food, Nutrient-Dense Dietary Intervention (Behavioral)

Standard-of Care Group

Placebo Comparator

This group will receive normal standard-of-care for pregnancy.

干预措施: Standard of Care (Behavioral)

结局指标

主要结局

Functional neuroconnectivity of neonate assessed by MRI

时间窗: 2-5 weeks after birth

MRI will be used to examine brain morphology and functional connectivity in the neonates.

次要结局

  • Blood nutrient concentrations(Assessed at consent and end of 3rd trimester)

研究者

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

Joel Nigg, Ph.D.

Director, Division of Psychology and Professor of Psychiatry

Oregon Health and Science University

研究点 (2)

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