CClinicalTrials.gg
Status unknownNCT03448952Updated Feb 28, 2018

Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

An observational study in Thrombocytopenia Neonatal, sponsored by Sylvia Elzek. Status unknown. Open to participants aged 1 Hour to 28 Days. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Sylvia Elzek · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
1 Hour to 28 Days
Sex
All
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Study 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.

Read the 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
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Conditions studied

  • Thrombocytopenia Neonatal

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03

Who can participate

Ages eligible
1 Hour to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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:

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-28 day after birth

  2. 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.

    Time frame: 1-28 day after birth

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03448952
Lead sponsor
Sylvia Elzek
Responsible party
Sylvia Elzek (principle investigator, Assiut University) — Sponsor-investigator
First posted
Feb 28, 2018
Start date
Mar 2019 (estimated)
Primary completion
Feb 2020 (estimated)
Completion
Feb 2020 (estimated)
Last update
Feb 28, 2018

Study contacts

Farouk Hassanen, MD
Contact
safwatabdelaziz371@yahoo.com
0882080645
Safwat Abd ElAziz, MD
Contact
safwatabdelaziz371@yahoo.com
01003918080
Safwat Abd ElAziz, MD
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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