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Clinical Trials/NCT03448952
NCT03448952
Unknown
Not Applicable

Incidence and Risk Factors for Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital

Sylvia Elzek0 sites150 target enrollmentMarch 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombocytopenia Neonatal
Sponsor
Sylvia Elzek
Enrollment
150
Primary Endpoint
risk factors of of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital.
Last Updated
8 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
March 2019
End Date
February 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sylvia Elzek
Responsible Party
Sponsor Investigator
Principal Investigator

Sylvia Elzek

principle investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • newborn (term and preterm, inborn or out born) aged from 1-28 day
  • platelet count below one hundred and fifty thousands unit/liter

Exclusion Criteria

  • Infant above 28 days old.
  • Newborns have platelet count one hundred and fifty thousands unit/liter
  • Exclusion Criteria:

Outcomes

Primary Outcomes

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.

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.

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