跳至主要内容
临床试验/NCT05211297
NCT05211297已完成不适用

Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.

Instituto de Investigación Sanitaria Aragón1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
Left ventricle (LV) systolic and diastolic function

研究概览

简要总结

Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years).

Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.

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 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Good understanding and sign of informed consent.

排除标准

  • Multiple pregnancy
  • Malformations
  • Chromosomal diseases
  • Prenatal infections

结局指标

主要结局

Left ventricle (LV) systolic and diastolic function

时间窗: 6-8 years

End-diastolic and end-systolic diameter, septum and posterior wall thickness, heart rate, ejection fraction (by Teicholz and biplane Simpson methods), mitral annulus S´ wave velocity (tissue doppler), mitral annulus E and A waves velocity (pulse-wave doppler), E´ and A´ waves velocity (tissue doppler), TEI index (tissue doppler) and LV strain and strain rate at three apical views (speckle tracking).

Visual development test

时间窗: 6-8 years

Body mass index and adiposity

时间窗: 6-8 years

General intelligence index

时间窗: 6-8 years

Global index of problems

时间窗: 6-8 years

Cardio-respiratory resistance

时间窗: 6-8 years

After fitting the safety harness, the test began when the participants were able to walk easily on the treadmill (Quasar Med 4.0, h/p/cosmos, Nußdorf, Germany). The protocol started with a speed of 2.4 km/h, increasing by 0.8 km/h every 2 min until the participants were unable to walk or reached a speed of 4.8 km/h. Then, the slope was increased by 4% every minute until exhaustion or up to a maximal slope of 24%. The respiratory gas exchange data were measured breath-by-breath using open-circuit spirometry (Oxycon Pro, Jaeger/Viasys Healthcare, Hoechberg, Germany). Maximal oxygen uptake (VO2max) values were averaged over consecutive 15 s periods.

Index of emotional problems

时间窗: 6-8 years

Percentage of fat mass and total and regional lean mass

时间窗: 6-8 years

Systolic and diastolic blood pressure

时间窗: 6-8 years

Index of behavioral problems

时间窗: 6-8 years

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigación Sanitaria Aragón
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Paules

Principal Investigator

Instituto de Investigación Sanitaria Aragón

研究点 (1)

Loading locations...

相似试验

Impact of Suspected Preterm Labour on... | 临床试验