NCT02639676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

4.8 years

First QC Date

December 10, 2015

Last Update Submit

February 22, 2022

Conditions

Preeclampsia

Keywords

InfantBronchopulmonary DysplasiaPremature

Outcome Measures

Primary Outcomes (1)

  • Infant lung development measured by diffusion lung capacity (DLCO)

    by month 8

Secondary Outcomes (1)

  • Airway function measured by spirometry

    by month 8

Other Outcomes (4)

  • 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.

    by month 8

  • Systemic vascular function measured by a vascular challenge on capillary density.

    by month 8

  • +1 more other outcomes

Study Arms (2)

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

Interventions

Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen CollectionsOTHER
Group 1: Infants born to mothers with preeclampsiaGroup 2: Infants born to mothers with normotensive pregnancies

Eligibility Criteria

Age26 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Normotensive pregnancy
  • Anticipated delivery at 26+0 weeks gestation or greater.
  • Maternal history of gestational diabetes
  • Multiple gestation
  • Genetic anomalies
  • Chest wall abnormalities
  • Chronic or Gestational hypertension
  • Cardiopulmonary defects
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Cord Blood, and Placenta Samples.

MeSH Terms

Conditions

Pre-EclampsiaBronchopulmonary DysplasiaPremature Birth

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor Complications

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Robert S Tepper, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 24, 2015

Study Start

February 11, 2016

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

US(1)