Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

Thrombocytopenia Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03448952
• Other study ID #: IRNT
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2018
• Last updated: February 27, 2018
• Start date: March 2019
• Est. completion date: February 2020

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: Farouk Hassanen, MD
• Phone: 0882080645
• Email: safwatabdelaziz371[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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:

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytopenia Neonatal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sylvia Elzek

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital.	measure the incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital.	1-28 day after birth
Primary	risk factors of of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital.	detect the risk factors of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assuit University Children Hospital.	1-28 day after birth