- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02639676
Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development
February 22, 2022 updated by: Robert Tepper, Indiana University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
292
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Group 1: Infants born to mothers with preeclampsia
Inclusion Criteria:
- 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.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1: Infants born to mothers with preeclampsia
Infants with expected delivery at 26+0 weeks gestation or greater .
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Group 2: Infants born to mothers with normotensive pregnancies
Infants with expected delivery at 26+0 weeks gestation or greater.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infant lung development measured by diffusion lung capacity (DLCO)
Time Frame: by month 8
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by month 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Airway function measured by spirometry
Time Frame: by month 8
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by month 8
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
by month 8
|
Systemic vascular function measured by a vascular challenge on capillary density.
Time Frame: by month 8
|
by month 8
|
Systemic vascular function measured by blood pressure.
Time Frame: by month 8
|
by month 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert S Tepper, MD, PhD, Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2016
Primary Completion (Actual)
November 17, 2020
Study Completion (Actual)
November 17, 2020
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 23, 2015
First Posted (Estimate)
December 24, 2015
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 22, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1509123588
- R01HL1222215 (Other Grant/Funding Number: National Heart, Lung, and Blood Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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