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Not yet recruitingNCT07882342Updated Oct 20, 2026

Neonatal Thrombocytopenia in the NICU

An observational study in Thrombocytopenia and Neonatal Thrombocytopenia, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Assiut University · Observational

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
Up to 28 Days
Sex
All
01

Study 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 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.

02

Conditions studied

  • Thrombocytopenia
  • Neonatal Thrombocytopenia

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Keywords

  • Neonatal thrombocytopenia
  • Platelet count
  • NICU
  • Severity
  • Assiut
03

In context

Thrombocytopenia

703 studies on the registry are indexed under Thrombocytopenia; 150 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 186 observational studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neonates aged 28 days or less admitted to the Neonatal Intensive Care Unit with platelet count less than 150 × 10⁹/L.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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

Exclusion criteria

Exclusion Criteria:

  • - Incomplete or missing medical records
  • Refusal of informed consent by parents or legal guardians
  • Major congenital anomalies incompatible with follow-up
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neonates with Thrombocytopenia

    Neonates admitted to the NICU with platelet count less than 150 × 10⁹/L.

06

What researchers measure

Primary outcomes

  1. Frequency of severe thrombocytopenia

    Percentage of neonates with platelet count less than 50 × 10⁹/L among those with thrombocytopenia.

    Time frame: Baseline

Secondary outcomes

  1. Frequency of early-onset thrombocytopenia

    Percentage of neonates with thrombocytopenia diagnosed within the first 72 hours of life.

    Time frame: Baseline

  2. Number of neonates requiring platelet transfusion

    Number of neonates who receive one or more platelet transfusions during admission.

    Time frame: At 28 days

  3. Number of neonates with intracranial hemorrhage

    Number of neonates diagnosed with intracranial hemorrhage on cranial ultrasound.

    Time frame: At 28 days

  4. Mortality rate

    Number of neonates who die during hospital admission.

    Time frame: At 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 54 non-industry observational studies under Thrombocytopenia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 120. This study's planned 12 months is below that.

Counting every sponsor, half of 58 studies reached it within 36 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 20, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Oct 20, 2027
CompletionEst.
Feb 25, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882342
Lead sponsor
Assiut University
Responsible party
Samer Ali Abd El Rahman Ali (Resident Physician, Department of Pediatrics, Assiut University) — Principal investigator
First posted
Oct 20, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Oct 20, 2027 (estimated)
Completion
Feb 25, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Samer A Andelrahman, Resident
Contact
Samer.17289860@med.aun.edu.eg
01062751089
Mostafa M Embaby, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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