Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively
研究概览
简要总结
The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.
详细描述
The overarching objective is to serially assess changes in the fetal circulation, heart, and brain with sophisticated ultrasound, MRI (Magnetic Resonance Imaging), and body composition techniques that will provide clues as to how growth restricted babies will tolerate life outside the uterus. Employing a longitudinal study will allow the investigators to correlate perinatal and postnatal outcomes more comprehensively than previous studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.
排除标准
- •Patients < 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
研究组 & 干预措施
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Ultrasound (Radiation)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: MRI (Radiation)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Blood collection (Procedure)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Neurological Function Assessment (Behavioral)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Placental Analysis (Procedure)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Measurement of body fat (Procedure)
Small for Gestational Age Pregancies (controls)
Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Pediatric heart ultrasound (Radiation)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Ultrasound (Radiation)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: MRI (Radiation)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Blood collection (Procedure)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Neurological Function Assessment (Behavioral)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Placental Analysis (Procedure)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Measurement of body fat (Procedure)
IUGR Pregnancies (cases)
Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
干预措施: Pediatric heart ultrasound (Radiation)
结局指标
主要结局
Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively
时间窗: Every two weeks from the time of IUGR diagnosis or first visit
Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.
次要结局
- Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes(Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years)
- Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes(Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years)
- Compare early IUGR, late IUGR and SGA infant and early childhood outcomes(Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years)
- Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment(Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years)