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New model may help decide which preterm babies need platelet transfusions

NCT ID NCT06043050

Knowledge-focused Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looked at data from over 1000 preterm babies with low platelet counts to build a model that predicts their risk of major bleeding or death. The goal is to help doctors decide when a platelet transfusion is truly needed, since current guidelines based only on platelet count may not be enough. The model considers each baby's changing condition over time to give personalized risk estimates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Platelet transfusion
What this could lead to
If successful, this model could help doctors decide which preterm babies truly need platelet transfusions, reducing unnecessary treatments and complications.
What could go wrong
This is an observational study, not a trial, so it can't prove cause and effect. The model needs further testing before it can be used in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,042 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Neonates with a gestational age below 34 weeks and at least one platelet count below 50x10\^9/L, admitted to a NICU between January 1st, 2017 and January 1st, 2022.

Ages

22 to 34 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Gestational age at birth \<34 weeks; 2. At least one platelet count \<50x109/L; 3. Admission to a participating tertiary care NICU, including postnatal transfers, between January 1st, 2017 and January 1st, 2022. Exclusion Criteria: 1. A severe congenital malformation; 2. Only spurious platelet counts \<50x109/L (e.g. clots in the sample, or a very rapid recovery to a normal platelet count without platelet transfusion); 3. Only platelet counts \<50x109/L in the context of exchange transfusion; 4. Major intracranial bleeding prior to the onset of severe thrombocytopenia. Neonates with major bleeding after the end of follow-up will not be excluded, but will be recorded as having had no major bleeding during the study.

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Conditions

The condition(s) this trial relates to.

Hemorrhage neonatal thrombocytopenia thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraventricular hemorrhage Neonatal thrombocytopenia Platelet transfusion

Contacts and locations

Locations

  • Amsterdam University Medical Center, Emma Children's hospital, location AMC

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Amsterdam University Medical Center, Emma Children's hospital, location VUmc

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Charité - Universitätsmedizin Berlin

    Berlin, Metropolregion Berlin-Brandenburg, 10117, Germany

  • Erasmus University Medical Center, Sophia pediatric hospital

    Rotterdam, South Holland, 3015 CN, Netherlands

  • Isala clinics

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Karolinska University Hospital

    Stockholm, Södermanland and Uppland, 171 76, Sweden

  • Leiden University Medical Center, Willem Alexander Children's hospital

    Leiden, South Holland, 2333 ZA, Netherlands

  • Maastricht University Medical Center, MosaKids

    Maastricht, Limburg, 6229 HX, Netherlands

  • Máxima Medical Center

    Veldhoven, North Brabant, 5504 DB, Netherlands

  • Radboud University Medical Center, Amalia Children's hospital

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • University Medical Center Groningen, Beatrix Children's hospital

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • University Medical Center Utrecht, Wilhelmina Children's hospital

    Utrecht, Utrecht, 3584 EA, Netherlands

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