Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

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

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.

Study Overview

• Status: Unknown
• Conditions: 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

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sylvia Elzek
• Investigators: Study Director: Safwat Abd ElAziz, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Blood Platelet Disorders; Thrombocytopenia; Thrombocytopenia, Neonatal Alloimmune
• Other Study ID Numbers: IRNT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No