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Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

NCT ID: NCT03448952

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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

Conditions

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Thrombocytopenia Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sylvia Elzek

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Elzek

principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Safwat Abd ElAziz, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Farouk Hassanen, MD

Role: CONTACT

Phone: 0882080645

Email: [email protected]

Safwat Abd ElAziz, MD

Role: CONTACT

Phone: 01003918080

Email: [email protected]

Other Identifiers

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IRNT

Identifier Type: -

Identifier Source: org_study_id