Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/19/2019 |
| Start Date: | November 2015 |
| End Date: | May 2020 |
| Contact: | Lauren Jewett, RN, BSN |
| Email: | lbjewett@iu.edu |
| Phone: | 317-944-3225 |
The Effects of Maternal Preeclampsia on the Development of Pulmonary and Vascular Dysfunction in Infants
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.
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.
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.
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.
Group 1: Infants born to mothers with preeclampsia
Inclusion Criteria:
- Clinical diagnosis of preeclampsia per the ACOG Task Force on Hypertension in
Pregnancy 2013 report
- Anticipated delivery at 26+0 weeks gestation or greater.
Exclusion Criteria:
- 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
We found this trial at
1
site
705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert S Tepper, MD, PhD
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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