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Trial record 26 of 29 for:    Pulmonary Hypertension OR Vascular dementia OR Vascular Dementia OR Vascular Contributions to Cognitive Impairment and Dementia | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development

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ClinicalTrials.gov Identifier: NCT02639676
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert Tepper, Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment
Preeclampsia Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Maternal Preeclampsia on the Development of Pulmonary and Vascular Dysfunction in Infants
Study Start Date : November 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020


Group/Cohort Intervention/treatment
Group 1: Infants born to mothers with preeclampsia
Infants with expected delivery at 26+0 weeks gestation or greater .
Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
Group 2: Infants born to mothers with normotensive pregnancies
Infants with expected delivery at 26+0 weeks gestation or greater.
Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections



Primary Outcome Measures :
  1. Infant lung development measured by diffusion lung capacity (DLCO) [ Time Frame: by month 8 ]

Secondary Outcome Measures :
  1. Airway function measured by spirometry [ Time Frame: by month 8 ]

Other Outcome Measures:
  1. Lung development measured by angiogenic growth factors: ratio of circulating progenitor cells to non circulating progenitor cells, vascular endothelial growth factor, and soluble fms-like tyrosine kinase-1 found in cord blood. [ Time Frame: by month 8 ]
  2. Systemic vascular function measured by angiogenic factors of the ratio of circulating progenitor cells to non progenitor cells, vascular endothelial growth factor, and soluble fms-like tyronsine kinase-1 found in cord blood. [ Time Frame: by month 8 ]
  3. Systemic vascular function measured by a vascular challenge on capillary density. [ Time Frame: by month 8 ]
  4. Systemic vascular function measured by blood pressure. [ Time Frame: by month 8 ]

Biospecimen Retention:   Samples With DNA
Blood, Cord Blood, and Placenta Samples.


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Ages Eligible for Study:   26 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators are recruiting two groups of infants born at 26+0 weeks and greater. The first group are infant's born to mother's with preeclampsia and the second are infants born to mother's with a normotensive pregnancy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639676


Contacts
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Contact: Lauren Jewett, RN, BSN 317-944-3225 lbjewett@iu.edu
Contact: Katia Rothhaar, PhD, MBA 317-944-3201 krothhaa@iu.edu

Locations
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United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Robert S Tepper, MD, PhD         
Sub-Investigator: David Haas, MD         
Sub-Investigator: Laura Haneline, MD         
Sponsors and Collaborators
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Robert S Tepper, MD, PhD Indiana University

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Responsible Party: Robert Tepper, MD, PhD, Indiana University
ClinicalTrials.gov Identifier: NCT02639676     History of Changes
Other Study ID Numbers: 1509123588
R01HL1222215 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute )
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Robert Tepper, Indiana University:
Infant
Bronchopulmonary Dysplasia
Premature
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications