ThrombocytopeniaNCT07882342
Neonatal Thrombocytopenia in the NICU
An observational study of Thrombocytopenia and Neonatal Thrombocytopenia, run by Assiut University.
Trial summary
This prospective cohort study aims to determine the frequency, severity, and clinical outcome of thrombocytopenia among neonates admitted to the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Thrombocytopenia, Neonatal Thrombocytopenia
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 25 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates aged 28 days or less admitted to the Neonatal Intensive Care Unit with platelet count less than 150 × 10⁹/L.
Who may be able to join
- - Neonates aged 28 days or less
- Admitted to the Neonatal Intensive Care Unit
- Platelet count less than 150 × 10⁹/L on at least one blood sample
- Written informed consent from parent or legal guardian
Who cannot join
- - Incomplete or missing medical records
- Refusal of informed consent by parents or legal guardians
- Major congenital anomalies incompatible with follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence, Risk Factors, Severity, and Outcome of Thrombocytopenia Among Neonates Admitted to the Neonatal Intensive Care Unit
This prospective cohort study aims to determine the frequency, severity, and clinical outcome of thrombocytopenia among neonates admitted to the neonatal intensive care unit.
Read the detailed description
Thrombocytopenia is a common hematological abnormality in neonates admitted to the neonatal intensive care unit. It may range from mild laboratory finding to severe disease with hemorrhagic complications.
This observational study will evaluate neonates with platelet count less than 150 × 10⁹/L admitted to the NICU to describe the frequency of different severity grades, timing of onset, and clinical outcomes including hemorrhagic complications and mortality.
- Conditions
- Thrombocytopenia, Neonatal Thrombocytopenia
- Keywords
- Neonatal thrombocytopenia, Platelet count, NICU, Severity, Assiut
- Medical subject headings
- Thrombocytopenia, Thrombocytopenia, Neonatal Alloimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with Thrombocytopenia | Neonates admitted to the NICU with platelet count less than 150 × 10⁹/L. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of severe thrombocytopenia
Percentage of neonates with platelet count less than 50 × 10⁹/L among those with thrombocytopenia.
Measured: Baseline
Secondary outcomes (4)
Frequency of early-onset thrombocytopenia
Percentage of neonates with thrombocytopenia diagnosed within the first 72 hours of life.
Measured: Baseline
Number of neonates requiring platelet transfusion
Number of neonates who receive one or more platelet transfusions during admission.
Measured: At 28 days
Number of neonates with intracranial hemorrhage
Number of neonates diagnosed with intracranial hemorrhage on cranial ultrasound.
Measured: At 28 days
Mortality rate
Number of neonates who die during hospital admission.
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Ali Abd El Rahman Ali, Assiut University
- Investigators
- Mostafa M Embaby, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882342
- Sponsor's protocol ID
- Neo-Thrombocytopenia-Assiut
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Risk Factors, Severity, and Outcome of Thrombocytopenia Among Neonates Admitted to the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07882342
- Acronym / sponsor ID
- Neo-Thrombocytopenia-Assiut
- Conditions
- Thrombocytopenia, Neonatal Thrombocytopenia
- Keywords
- Neonatal thrombocytopenia, Platelet count, NICU, Severity, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 20 Oct 2026 (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.
This prospective cohort study aims to determine the frequency, severity, and clinical outcome of thrombocytopenia among neonates admitted to the neonatal intensive care unit.
Detailed description
Thrombocytopenia is a common hematological abnormality in neonates admitted to the neonatal intensive care unit. It may range from mild laboratory finding to severe disease with hemorrhagic complications.
This observational study will evaluate neonates with platelet count less than 150 × 10⁹/L admitted to the NICU to describe the frequency of different severity grades, timing of onset, and clinical outcomes including hemorrhagic complications and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with Thrombocytopenia | – | –Neonates admitted to the NICU with platelet count less than 150 × 10⁹/L. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates aged 28 days or less admitted to the Neonatal Intensive Care Unit with platelet count less than 150 × 10⁹/L.
Key inclusion criteria (4 listed)
- - Neonates aged 28 days or less
- Admitted to the Neonatal Intensive Care Unit
- Platelet count less than 150 × 10⁹/L on at least one blood sample
- Written informed consent from parent or legal guardian
Key exclusion criteria (3 listed)
- - Incomplete or missing medical records
- Refusal of informed consent by parents or legal guardians
- Major congenital anomalies incompatible with follow-up
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
Frequency of severe thrombocytopenia
Time frame: Baseline
Percentage of neonates with platelet count less than 50 × 10⁹/L among those with thrombocytopenia.
4 secondary outcomes
Frequency of early-onset thrombocytopenia
Time frame: Baseline
Number of neonates requiring platelet transfusion
Time frame: At 28 days
Number of neonates with intracranial hemorrhage
Time frame: At 28 days
Mortality rate
Time frame: At 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Thrombocytopenia
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RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
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RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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.
Mostafa M Embaby, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Neonatal Thrombocytopenia, run by Assiut University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samer A Andelrahman, Resident (01062751089, Samer.17289860@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of severe thrombocytopenia (time frame: Baseline). 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 20 Oct 2026.