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临床试验/NCT02639676
NCT02639676已完成不适用

The Effects of Maternal Preeclampsia on the Development of Pulmonary and Vascular Dysfunction in Infants

Indiana University1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2016年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
292
试验地点
1
主要终点
Infant lung development measured by diffusion lung capacity (DLCO)

研究概览

简要总结

Pregnant mothers who develop high blood pressure and other vascular problems (preeclampsia) deliver babies with increased neonatal health problems, which include lung disease and vascular complications, later in life. Investigators will evaluate whether infants of mothers with preeclampsia have evidence for impaired development of the lungs and blood vessels.

详细描述

The overall objective of this study is to determine whether the anti-angiogenic environment of preeclampsia results in pulmonary and vascular dysfunction in infants. Specifically, study investigators hypothesize that the anti- angiogenic environment of preeclampsia will impair pulmonary development and promote vascular dysfunction in infants. Furthermore, study investigators hypothesize that circulating progenitor cell (CPC) measurements in cord blood will correlate with infant pulmonary (Aim #1) and systemic vascular (Aim #2) function. Study investigators will determine whether the pro-angiogenic circulating progenitor cells (CPC) versus non-circulating progenitor cells ratio in cord blood of pregnancies complicated by preeclampsia predicts pulmonary diffusing capacity and systemic vascular dysfunction, as well as respiratory distress syndrome (RDS) and bronchopulmonary dysplasia (BPD). This research represents an important translational study that extends observations made in pre-clinical animal models that have clearly established a critical relationship between angiogenesis and lung development. Preliminary data strongly suggest a relationship between pro-angiogenic circulating progenitor cells (CPCs), bronchopulmonary dysplasia (BPD), and pulmonary diffusion in human infants. Investigators will evaluate whether circulating progenitor cells (CPC)s are a biomarker for developing bronchopulmonary dysplasia (BPD), investigators will relate circulating progenitor cells (CPCs) to the underlying pathophysiology, as assessed by pulmonary function testing methods that we developed for this very difficult age group to evaluate. A positive finding in the study would provide the rationale for future translational studies evaluating the therapeutic potential of circulating progenitor cells (CPCs) to stimulate lung development of premature infants, as there are currently no known therapeutic interventions that minimize or prevent the development of bronchopulmonary dysplasia (BPD). One of several approaches could be applied in the future to increase circulating progenitor cells (CPCs) in premature infants: 1) pharmacologic mobilization of pro-angiogenic cells from the bone marrow, 2) expansion of pro-angiogenic cells from an infant's cord blood for autologous infusion, and 3) transfusion of pooled pro-angiogenic cells from multiple donors.

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
26 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of preeclampsia per the American College of Obstetricians and Gynecologists (ACOG) Task Force on Hypertension in Pregnancy 2013 report
  • Anticipated delivery at 26+0 weeks gestation or greater.

排除标准

  • Infant is not viable
  • Cardiopulmonary defects
  • Chest wall abnormalities
  • Genetic anomalies
  • Maternal history of Diabetes Mellitus
  • Multiple gestation
  • Group 2: Infants born to mothers with normotensive pregnancies
  • Inclusion Criteria
  • Normotensive pregnancy
  • Anticipated delivery at 26+0 weeks gestation or greater.
  • Exclusion Criteria
  • Maternal history of gestational diabetes
  • Multiple gestation
  • Genetic anomalies
  • Chest wall abnormalities
  • Chronic or Gestational hypertension
  • Cardiopulmonary defects
  • Infant is not viable

结局指标

主要结局

Infant lung development measured by diffusion lung capacity (DLCO)

时间窗: by month 8

次要结局

  • Airway function measured by spirometry(by month 8)

研究者

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

Robert Tepper

MD, PhD

Indiana University

研究点 (1)

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