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Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03448952
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sylvia Elzek, Assiut University

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
Thrombocytopenia Neonatal

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

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital. [ Time Frame: 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. [ Time Frame: 1-28 day after birth ]
    detect the risk factors of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assuit University Children Hospital.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include all newborns with thrombocytopenia either preterm or full term, inborn or out born cases who admitted to neonatal intensive care unit of Assiut University Children Hospital through one year.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448952


Contacts
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Contact: Farouk Hassanen, MD 0882080645 safwatabdelaziz371@yahoo.com
Contact: Safwat Abd ElAziz, MD 01003918080 safwatabdelaziz371@yahoo.com

Sponsors and Collaborators
Sylvia Elzek
Investigators
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Study Director: Safwat Abd ElAziz, MD Assiut University

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Responsible Party: Sylvia Elzek, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03448952     History of Changes
Other Study ID Numbers: IRNT
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Thrombocytopenia, Neonatal Alloimmune
Blood Platelet Disorders
Hematologic Diseases
Infant, Newborn, Diseases