PreeclampsiaNCT02639676
Anti-Angiogenic Preeclampsia Milieu Impairs Infant Lung and Vascular Development
An observational study of Preeclampsia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 weeks and older
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2016to 17 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- Normotensive pregnancy
- Anticipated delivery at 26+0 weeks gestation or greater.
Who cannot join
- Infant is not viable
- Cardiopulmonary defects
- Chest wall abnormalities
- Genetic anomalies
- Maternal history of Diabetes Mellitus
- Multiple gestation
Show all 14Show fewer
- Group 2: Infants born to mothers with normotensive pregnancies
- Maternal history of gestational diabetes
- Multiple gestation
- Genetic anomalies
- Chest wall abnormalities
- Chronic or Gestational hypertension
- Cardiopulmonary defects
- Infant is not viable
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections
- Keywords
- Infant, Bronchopulmonary Dysplasia, Premature
- Medical subject headings
- Pre-Eclampsia, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen CollectionsOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Infants born to mothers with preeclampsia | Infants with expected delivery at 26+0 weeks gestation or greater . Receives: 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. Receives: Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant lung development measured by diffusion lung capacity (DLCO)
Measured: by month 8
Secondary outcomes (1)
Airway function measured by spirometry
Measured: by month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start11 Feb 2016
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Robert Tepper, Indiana University
- Investigators
- Robert S Tepper, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639676
- Sponsor's protocol ID
- 1509123588
- Other IDs
- R01HL1222215
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2015
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Maternal Preeclampsia on the Development of Pulmonary and Vascular Dysfunction in Infants
- ClinicalTrials.gov ID
- NCT02639676
- Acronym / sponsor ID
- 1509123588
- Conditions
- Preeclampsia
- Keywords
- Infant, Bronchopulmonary Dysplasia, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Infants born to mothers with preeclampsia | – | Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen CollectionsInfants with expected delivery at 26+0 weeks gestation or greater . |
| Group 2: Infants born to mothers with normotensive pregnancies | – | Other: Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen CollectionsInfants with expected delivery at 26+0 weeks gestation or greater. |
Who may qualify
- Ages
- 26 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- Normotensive pregnancy
- Anticipated delivery at 26+0 weeks gestation or greater.
Key exclusion criteria (14 listed)
- Infant is not viable
- Cardiopulmonary defects
- Chest wall abnormalities
- Genetic anomalies
- Maternal history of Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections | Other | Group 1: Infants born to mothers with preeclampsia, Group 2: Infants born to mothers with normotensive pregnancies |
Primary outcome
Infant lung development measured by diffusion lung capacity (DLCO)
Time frame: by month 8
1 secondary outcome
Airway function measured by spirometry
Time frame: by month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Tepper, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant lung development measured by diffusion lung capacity (DLCO) (time frame: by month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.