Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 13
- 主要终点
- childrens behaviour
研究概览
简要总结
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention).
From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany.
In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.
详细描述
Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.
In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mothers participation in one of the PETN studies
- •age above 5 years
- •completion of questionnaires for self reported data
- •written consent for physical examination
- •Exclusion Criteria - only physical examination:
- •physical and mental states preventing physical examination
排除标准
- 未提供
结局指标
主要结局
childrens behaviour
时间窗: up to 2 years after study inclusion
total score of either CBCL/16-18R or YSR/11-18R
次要结局
- epigenetic analysis(age of 6 to 8 years)
- IQ development(age of 6 to 8 years)
- physical development weight(up to 2 years after study inclusion)
- age appropriate development(up to 2 years after study inclusion)
- cardiovascular development(age of 6 to 8 years)
- motoric development(age of 6 to 8 years)
- symptoms of attention and activity disorders(age of 6 to 8 years)
- physical development height(up to 2 years after study inclusion)
- cognitive, motoric, and exectuve function(up to 2 years after study inclusion)
- physical development(age above 10 years)
- attention behaviour(age of 6 to 8 years)
- neurocognitive development(age of 6 to 8 years)
研究者
Tanja Groten
Deputy Head of Department of Obstetrics
Jena University Hospital