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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL1222215 | Other Grant/Funding Number | National Heart, Lung, and Blood Institute |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Infants born to mothers with preeclampsia | Infants with expected delivery at 26+0 weeks gestation or greater . |
| |
| Group 2: Infants born to mothers with normotensive pregnancies | Infants with expected delivery at 26+0 weeks gestation or greater. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant lung development measured by diffusion lung capacity (DLCO) | by month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Airway function measured by spirometry | by month 8 |
| Measure | Description | 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. | 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. |
Group 1: Infants born to mothers with preeclampsia
Inclusion Criteria:
Exclusion Criteria:
Group 2: Infants born to mothers with normotensive pregnancies
Inclusion Criteria
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Tepper, MD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood, Cord Blood, and Placenta Samples.
| by month 8 |
| Systemic vascular function measured by a vascular challenge on capillary density. | by month 8 |
| Systemic vascular function measured by blood pressure. | by month 8 |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |