Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

Sponsor
Sylvia Elzek (Other)
Overall Status
Unknown status
CT.gov ID
NCT03448952
Collaborator
(none)
150
11.1

Study Details

Study Description

Brief Summary

Thrombocytopenia is diagnosed when platelet count is lower than 150,000 U/L, it is a common hemostatic problem in neonatal intensive care units According to platelets count, it is classified into mild thrombocytopenia with platelet count 100,000 to 150,000 U/L, moderate thrombocytopenia with platelet count 50,000 to 100,000 U/L and severe thrombocytopenia that have platelet count less than or equal to 50,000 U/L.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Platelets are seen under microscope as small anucleated fragments of megakaryocytes that circulate in the blood as discs with an average volume of about 7.5 fimtolitre , 14 times smaller than erythrocytes. Platelets count in premature infant is slightly lower than that of healthy term infant but is still within the normal range (150,000 to 450,000 unit/ litre ).

    The most common risk factors for thrombocytopenia are

    1. Sepsis: Thrombocytopenia is a frequent problem in neonatal sepsis and is among the most predictive, independent risk factors for sepsis-associated mortality

    2. Low birth weight: It is recorded that thrombocytopenia was more common among the smallest patients; 85% incidence among those ⩽800 gram, 60% among those 801 to 900 gram, and 53% among those 901 to 1000 gram

    3. Perinatal asphyxia: Thrombocytopenia occurred in 31% of neonates with asphyxia versus 5% of matched non asphyxiated controls admitted to a neonatal intensive care unit

    4. Prematurity: In a normal pregnancy, the fetal platelet count reaches adult levels (150-450 × 106/ millilitre) by the second trimester of pregnancy. Thrombocytopenia , defined as less than 150,000/ millilitre, occurs in 18 to 40% of all preterm neonates (gestational age <37 weeks) admitted to neonatal intensive care units

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Incidence and Risk Factors for Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital
    Anticipated Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Feb 1, 2020
    Anticipated Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital. [1-28 day after birth]

      measure the incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital.

    2. risk factors of of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital. [1-28 day after birth]

      detect the risk factors of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assuit University Children Hospital.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Hour to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. newborn (term and preterm, inborn or out born) aged from 1-28 day

    2. platelet count below one hundred and fifty thousands unit/liter

    Exclusion Criteria:
    1. Infant above 28 days old.

    2. Newborns have platelet count one hundred and fifty thousands unit/liter

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sylvia Elzek

    Investigators

    • Study Director: Safwat Abd ElAziz, MD, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sylvia Elzek, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03448952
    Other Study ID Numbers:
    • IRNT
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Feb 28, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2018