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Trial record 1 of 1 for:    NCT02639676
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Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development

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ClinicalTrials.gov Identifier: NCT02639676
Recruitment Status : Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert Tepper, Indiana University

Tracking Information
First Submitted Date December 10, 2015
First Posted Date December 24, 2015
Last Update Posted Date August 5, 2020
Study Start Date November 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2015)
Infant lung development measured by diffusion lung capacity (DLCO) [ Time Frame: by month 8 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 23, 2015)
Airway function measured by spirometry [ Time Frame: by month 8 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 23, 2015)
  • 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 ]
  • 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 ]
  • Systemic vascular function measured by a vascular challenge on capillary density. [ Time Frame: by month 8 ]
  • Systemic vascular function measured by blood pressure. [ Time Frame: by month 8 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development
Official Title The Effects of Maternal Preeclampsia on the Development of Pulmonary and Vascular Dysfunction in Infants
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, Cord Blood, and Placenta Samples.
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.
Condition Preeclampsia
Intervention Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
Study Groups/Cohorts
  • Group 1: Infants born to mothers with preeclampsia
    Infants with expected delivery at 26+0 weeks gestation or greater .
    Intervention: 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.
    Intervention: Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 6, 2020)
400
Original Estimated Enrollment
 (submitted: December 23, 2015)
200
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 26 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02639676
Other Study ID Numbers 1509123588
R01HL1222215 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Robert Tepper, Indiana University
Study Sponsor Indiana University
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert S Tepper, MD, PhD Indiana University
PRS Account Indiana University
Verification Date August 2020