Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

February 27, 2018 updated by: Sylvia Elzek

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1-28 day after birth
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.
1-28 day after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sylvia Elzek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Safwat Abd ElAziz, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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