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Cardiovascular Changes in Infants of Preeclampsia Mother

Primary Purpose

Pre-Eclampsia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiovascular and immunological changes
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pre-Eclampsia

Eligibility Criteria

1 Minute - 3 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants born from Pregnant women with preeclampsia, their mother willing to give consent.

Exclusion Criteria:

  • 1-Infant with a major heart problem.
  • Infants with major congenital and genetic anomalies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    study group

    control group

    Arm Description

    new-born infants born from preeclampsia mother

    new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race

    Outcomes

    Primary Outcome Measures

    Cardiac changes
    cardiac output will be presented by ml/minute
    Cardiac function changes
    Fractional shortening and ejection fraction will be presented by percentage
    Vascular changes in superior mesenteric and anterior cerebral arteries
    Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second

    Secondary Outcome Measures

    Feeding problem
    rate of necrotizing enterocolitis and feeding intolerance
    oval all outcomes
    Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
    immunological changes
    interleukins level

    Full Information

    First Posted
    January 4, 2021
    Last Updated
    January 17, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04699825
    Brief Title
    Cardiovascular Changes in Infants of Preeclampsia Mother
    Official Title
    Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    April 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Preeclampsia (hypertension during pregnancy) is a common problem affecting 2-8% of pregnancies worldwide and is typically diagnosed by increased blood pressure and proteinuria. The rate of preeclampsia has increased since the 1980s with higher rates at extreme maternal ages as well as during the first pregnancy. Pre-eclampsia is a serious hypertensive disorder of pregnancy affecting outcomes for both mother and infants. These infants not only have increased risk of neonatal complications including preterm birth, intrauterine growth restriction, abnormal Doppler parameters, feed intolerance, intestinal problem, poor growth, and long term lung condition but also have increased risk of cerebral palsy, abnormal neurodevelopmental outcomes, cardiovascular disease, stroke, and mental disorders during childhood and adulthood.
    Detailed Description
    Preeclampsia is diagnosed according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria: BP > 140/90 on two occasions in previous normotensive mother after 20 weeks of gestation and one of the following; proteinuria in urine > 0.3 gram/kg/day or acute kidney or liver dysfunction or signs of uterine dysfunction. The onset of preeclampsia can be early before 34 weeks of pregnancy (Early-onset preeclampsia) or late after 34 weeks of pregnancy (Late-onset preeclampsia). Early-onset preeclampsia, especially between 28-32 weeks gestation, is characterized by a high prevalence of microvascular changes in the placenta that makes mothers and their infants are more liable to complication. The pathogenesis of preeclampsia is unclear. Preeclampsia affects hematopoiesis and the fetal myeloid lineage leading to thrombocytopenia, neutropenia, decrease phagocytic function, decrease T regulatory cells, and an increase in cytotoxic natural killer cells in neonates. Innate and adaptive immunity are regulated by myeloid cells and the immune changes in infants of preeclampsia mothers could lead to increased incidence of neonatal sepsis and the development of chronic inflammatory conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-Eclampsia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    new-born infants born from preeclampsia mother
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race
    Intervention Type
    Other
    Intervention Name(s)
    Cardiovascular and immunological changes
    Intervention Description
    performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
    Primary Outcome Measure Information:
    Title
    Cardiac changes
    Description
    cardiac output will be presented by ml/minute
    Time Frame
    within 72 hours after birth
    Title
    Cardiac function changes
    Description
    Fractional shortening and ejection fraction will be presented by percentage
    Time Frame
    within 72 hours after birth
    Title
    Vascular changes in superior mesenteric and anterior cerebral arteries
    Description
    Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second
    Time Frame
    72 hours after birth
    Secondary Outcome Measure Information:
    Title
    Feeding problem
    Description
    rate of necrotizing enterocolitis and feeding intolerance
    Time Frame
    3 months after birth
    Title
    oval all outcomes
    Description
    Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
    Time Frame
    3 months
    Title
    immunological changes
    Description
    interleukins level
    Time Frame
    cord blood at birth

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Minute
    Maximum Age & Unit of Time
    3 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants born from Pregnant women with preeclampsia, their mother willing to give consent. Exclusion Criteria: 1-Infant with a major heart problem. Infants with major congenital and genetic anomalies.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed S Ali
    Phone
    7309405405
    Email
    ahmedsalehali@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No, we will take consent from participant in this study only.
    Citations:
    PubMed Identifier
    24201165
    Citation
    Ananth CV, Keyes KM, Wapner RJ. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564. doi: 10.1136/bmj.f6564.
    Results Reference
    background
    PubMed Identifier
    20004912
    Citation
    Hansen AR, Barnes CM, Folkman J, McElrath TF. Maternal preeclampsia predicts the development of bronchopulmonary dysplasia. J Pediatr. 2010 Apr;156(4):532-6. doi: 10.1016/j.jpeds.2009.10.018. Epub 2009 Dec 14.
    Results Reference
    background
    PubMed Identifier
    29113524
    Citation
    Marins LR, Anizelli LB, Romanowski MD, Sarquis AL. How does preeclampsia affect neonates? Highlights in the disease's immunity. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1205-1212. doi: 10.1080/14767058.2017.1401996. Epub 2017 Nov 20.
    Results Reference
    background
    PubMed Identifier
    14986803
    Citation
    Bujold E, Chaiworapongsa T, Romero R, Gervasi MT, Espinoza J, Goncalves LF, Berman S, Yoon BH, Kim YM. Neonates born to pre-eclamptic mothers have a higher percentage of natural killer cells (CD3-/CD56+16+) in umbilical cord blood than those without pre-eclampsia. J Matern Fetal Neonatal Med. 2003 Nov;14(5):305-12. doi: 10.1080/jmf.14.5.305.312.
    Results Reference
    background
    PubMed Identifier
    16813742
    Citation
    Ness RB, Sibai BM. Shared and disparate components of the pathophysiologies of fetal growth restriction and preeclampsia. Am J Obstet Gynecol. 2006 Jul;195(1):40-9. doi: 10.1016/j.ajog.2005.07.049. Epub 2006 Apr 21.
    Results Reference
    background

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