Cardiovascular Effects of Prenatal Methamphetamine Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.
研究概览
简要总结
Methamphetamine (MA) is one of the commonly used drugs during pregnancy. Cardiovascular effects of MA include elevated blood pressure, acute vasospasm, atherosclerotic disease, structural and electrical remodeling of cardiac tissue leading to arrhythmias and heart failure, and pulmonary hypertension.1 In addition, MA can cause neurotoxicity with harmful effects on neurodevelopment in the children who had prenatal exposure.5-8 Currently neonatal providers do not perform detailed cardiovascular evaluation in newborn period or long term neurodevelopmental assessments as outpatient for the newly born infants with prenatal exposure to MA, and they do not qualify for early intervention. The goal of the investigators is to perform detailed cardiovascular evaluation in neonatal period and estimate baseline prevalences and follow up with developmental and cardiovascular assessment using a questionnaire at 12 months in a cohort of neonates enriched with those who had prenatal exposure to MA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born at UCDCH and at AHRO at gestational age >34 weeks. (<34 weeks excluded to avoid the effects of prematurity)
- •For the MA exposed subgroup (n=30): Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant.
- •For the MA unexposed subgroup (n=12): Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.
排除标准
- •a) Presence of congenital anomalies and known fatal conditions.
结局指标
主要结局
Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.
时间窗: Through study completion, an average of 2 years.
Perfusion index by pulse-oximeter, heart function by echocardiogram, EKG and detailed cardiac exam in the newborn period between 24-48 hours after birth.
Estimation of prevalence of MA use among births
时间窗: Through study completion, an average of 2 years.
次要结局
- Infant's neurodevelopmental outcome and general assessment at 12 months of age.(Through study completion, an average of 2 years.)