Thrombocytopenia NeonatalNCT03448952
Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit
An observational study of Thrombocytopenia Neonatal, run by Sylvia Elzek.
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… Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Thrombocytopenia Neonatal
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- newborn (term and preterm, inborn or out born) aged from 1-28 day
- platelet count below one hundred and fifty thousands unit/liter
Who cannot join
- Infant above 28 days old.
- Newborns have platelet count one hundred and fifty thousands unit/liter
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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
- Sepsis: Thrombocytopenia is a frequent problem in neonatal sepsis and is among the most predictive, independent risk factors for sepsis-associated mortality
- 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
- Perinatal asphyxia: Thrombocytopenia occurred in 31% of neonates with asphyxia versus 5% of matched non asphyxiated controls admitted to a neonatal intensive care unit
- 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
- Thrombocytopenia Neonatal
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-28 day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startMar 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sylvia Elzek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvia Elzek, Assiut University
- Investigators
- Safwat Abd ElAziz, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448952
- Sponsor's protocol ID
- IRNT
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03448952
- Acronym / sponsor ID
- IRNT
- Conditions
- Thrombocytopenia Neonatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sylvia ElzekUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Sepsis: Thrombocytopenia is a frequent problem in neonatal sepsis and is among the most predictive, independent risk factors for sepsis-associated mortality
- 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
- Perinatal asphyxia: Thrombocytopenia occurred in 31% of neonates with asphyxia versus 5% of matched non asphyxiated controls admitted to a neonatal intensive care unit
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- newborn (term and preterm, inborn or out born) aged from 1-28 day
- platelet count below one hundred and fifty thousands unit/liter
Key exclusion criteria (2 listed)
- Infant above 28 days old.
- Newborns have platelet count one hundred and fifty thousands unit/liter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safwat Abd ElAziz, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia Neonatal, run by Sylvia Elzek.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farouk Hassanen, MD (0882080645, safwatabdelaziz371@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of thrombocytopenia in newborn admitted to neonatal intensive care unit of Assiut University Children Hospital. (time frame: 1-28 day after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.