Neonatal ThrombocytopeniaPROSPECTNCT06043050
PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia
An observational study of Neonatal Thrombocytopenia and Intraventricular Hemorrhage, run by Leiden University Medical Center at 12 sites in 3 countries.
Trial summary
Preterm neonates often receive platelet transfusions when their platelet count is low to prevent bleeding. However, it is currently unclear which infants benefit from such transfusions. Read more about this study
- Who is it for?
- Ages 22 to 34 weeks
- Conditions the study is for
- Neonatal Thrombocytopenia, Intraventricular Hemorrhage, Platelet Transfusion
- What is being tested?
- Platelets
- How many people
- 1,042 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 26 Sep 2022to 30 Apr 2024
- 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 22 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Gestational age at birth <34 weeks;
- At least one platelet count <50x109/L;
- Admission to a participating tertiary care NICU, including postnatal transfers, between January 1st, 2017 and January 1st, 2022.
Who cannot join
- A severe congenital malformation;
- 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);
- Only platelet counts <50x109/L in the context of exchange transfusion;
- 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.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Netherlands10 sites
Amsterdam University Medical Center, Emma Children's hospital, location VUmc
Amsterdam, North Holland, 1081 HV
Amsterdam University Medical Center, Emma Children's hospital, location AMC
Amsterdam, North Holland, 1105 AZ
University Medical Center Groningen, Beatrix Children's hospital
Groningen, Provincie Groningen, 9713 GZ
Leiden University Medical Center, Willem Alexander Children's hospital
Leiden, South Holland, 2333 ZA
Maastricht University Medical Center, MosaKids
Maastricht, Limburg, 6229 HX
Radboud University Medical Center, Amalia Children's hospital
Nijmegen, Gelderland, 6525 GA
Erasmus University Medical Center, Sophia pediatric hospital
Rotterdam, South Holland, 3015 CN
University Medical Center Utrecht, Wilhelmina Children's hospital
Utrecht, Utrecht, 3584 EA
Máxima Medical Center
Veldhoven, North Brabant, 5504 DB
Isala clinics
Zwolle, Overijssel, 8025 AB
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, Metropolregion Berlin-Brandenburg, 10117
Sweden1 site
Karolinska University Hospital
Stockholm, Södermanland and Uppland, 171 76
About this study
Official title: Sequential Predictions Under Repeated Interventions: Estimating the Risk of Major Bleeding or Death With and Without Prophylactic Platelet Transfusion in Thrombocytopenic Neonates.
Preterm neonates often receive platelet transfusions when their platelet count is low to prevent bleeding. However, it is currently unclear which infants benefit from such transfusions. A recent randomized controlled trial (PlaNeT-2/MATISSE trial) showed that the higher platelet count threshold for transfusion was associated with a higher risk of major bleeding or death. Current transfusion protocols are based only on platelet count thresholds. However, neonates with similar platelet counts may have different bleeding risks due to varying clinical conditions. There is an important unmet medical need to identify which neonates with low platelet counts (i.e., severe thrombocytopenia) will benefit from a transfusion. Ideally, clinicians would be able to repeatedly predict a neonate's risk of major bleeding or death with and without giving a platelet transfusion, taking into account the neonate's clinical condition at that particular time. Obtaining personalized risk estimates under specific treatment strategies, with updated predictions at each new treatment decision moment, is called 'sequential prediction under interventions'. The investigators set up an international multicenter observational cohort study to develop a model to predict major bleeding or death with and without platelet transfusion at any time point during the first week after the onset of severe thrombocytopenia. This model is designed to support platelet transfusion decisions in the NICU and may help clinicians balance the benefits and harms of platelet transfusion based on updated characteristics of the neonate at the time of prediction.
Read the detailed description
Main objective: To develop a sequential interventional prediction model to support transfusion decisions by predicting the risk of major bleeding or death with and without giving a platelet transfusion to neonates with severe thrombocytopenia (i.e., platelet count below 50x10^9/L), conditional on their characteristics present at the moment of prediction.
Study design: Multicenter international observational cohort study.
Study population: Neonates with a gestational age below 34 weeks and at least one platelet count below 50x10^9/L, admitted to a neonatal intensive care unit (NICU) between January 1st 2017 and January 1st 2022.
Main study endpoint: Major bleeding or mortality during NICU admission
Assessments: Only routine care data will be collected. This includes platelet counts and transfusions, cranial (head) ultrasounds and other information on bleeding, and multiple clinical variables.
Statistical analyses: Development of a sequential prediction model under interventions using the cloning-censoring-weighting approach with inverse probability weighting. Validation of the model in a separate cohort of preterm neonates with severe thrombocytopenia.
- Being tested
- Platelets
- Keywords
- Sequential prediction under interventions, Causal prediction, Hemorrhage, Neonate, Thrombocytopenia
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune, Hemorrhage, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlateletsDrug
Also called Platelet transfusion
Observational data: all platelet transfusions recorded in routine care medical file data.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with severe thrombocytopenia | Neonates with a gestational age below 34 weeks and at least one platelet count below 50x10^9/L, who were admitted to a NICU between January 1st, 2017 and January 1st, 2022. Receives: Drug: Platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of major bleeding or death during NICU admission is the primary outcome. Neonates who first had a major bleeding and then died reach the endpoint at the time of the major bleeding.
The investigators defined major bleeding as either one of the following:
- Intraventricular hemorrhage (IVH) grade 3 or IVH of any grade in combination with parenchymal involvement (according to the Volpe grading system);
- Parenchymal hemorrhage (without IVH) or cerebellar hemorrhage (>4 mm visible on cranial ultrasound, not if ≤4 mm visible on MRI only);
- Pulmonary hemorrhage, defined as a fresh bleed from the trachea requiring intubation or ventilation, or a fresh bleed from the tube requiring increased ventilatory requirements;
- Any type of severe hemorrhage, including gastrointestinal bleeding, if associated with hemodynamic instability (e.g., hypotension) and/or requiring one of the following interventions within 24h*:
- Red blood cell transfusion
- Volume boluses
- Inotropes (either start of inotropes, or increased dose of current therapy)
Measured: From onset of severe thrombocytopenia until one week thereafter. The risk of major bleeding or death is predicted within 3 days and within 14 days from each moment of prediction during this time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start26 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neonatal ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Retrospective
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanquin Research & Blood Bank Divisions, Amsterdam University Medical Center
- Responsible party
- Principal investigator, Hilde van der Staaij, MD, Leiden University Medical Center
- Investigators
- Hilde van der Staaij, MD, Study director, Leiden University Medical Center and Sanquin Blood Supply FoundationJohanna G van der Bom, MD/PhD/Prof, Principal investigator, Leiden University Medical CenterCamila Caram-Deelder, MSc/PhD, Principal investigator, Leiden University Medical CenterEnrico Lopriore, MD/PhD/Prof, Principal investigator, Leiden University Medical CenterKarin Fijnvandraat, MD/PhD/Prof, Principal investigator, Amsterdam University Medical CenterSuzanne F Fustolo-Gunnink, MD/PhD, Principal investigator, Sanquin Blood Supply FoundationWes Onland, MD/PhD, Principal investigator, Amsterdam University Medical CenterNan van Geloven, MSc/PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043050
- Sponsor's protocol ID
- 22-3028
- Acronym
- PROSPECT
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitivity of the data, the underlying data sets will not be shared publicly due to ethical/privacy restrictions. However, all analyses will be documented, reproducible and available for audit. The data dictionary will be available upon request or as appendix in the manuscript. We might consider restricted access to the raw data in a repository when the target journal deems this necessary for publication. For future collaboration with the research partners or for data transfer/sharing, written agreements on data management, privacy, data ownership and intellectual properties will be made, such as a research collaboration agreement and data sharing agreement, and discussed with the support of Legal/Privacy/RDM experts where appropriate. In line with the Netherlands Code of Conduct for Research Integrity, raw and processed will be stored for a period of at least 10 years. The LUMC has long-term storage with back-up available for this.
Publications
Curley A, Stanworth SJ, Willoughby K, Fustolo-Gunnink SF, Venkatesh V, Hudson C, Deary A, Hodge R, Hopkins V, Lopez Santamaria B, Mora A, Llewelyn C, D'Amore A, Khan R, Onland W, Lopriore E, Fijnvandraat K, New H, Clarke P, Watts T; PlaNeT2 MATISSE Collaborators. Randomized Trial of Platelet-Transfusion Thresholds in Neonates. N Engl J Med. 2019 Jan 17;380(3):242-251. doi: 10.1056/NEJMoa1807320. Epub 2018 Nov 2.
PubMed 30387697Davenport P, Sola-Visner M. Hemostatic Challenges in Neonates. Front Pediatr. 2021 Mar 2;9:627715. doi: 10.3389/fped.2021.627715. eCollection 2021.
PubMed 33738269Davenport PE, Wood TR, Heagerty PJ, Sola-Visner MC, Juul SE, Patel RM. Platelet Transfusion and Death or Neurodevelopmental Impairment in Children Born Extremely Preterm. JAMA Netw Open. 2024 Jan 2;7(1):e2352394. doi: 10.1001/jamanetworkopen.2023.52394.
PubMed 38261320Fustolo-Gunnink SF, Fijnvandraat K, van Klaveren D, Stanworth SJ, Curley A, Onland W, Steyerberg EW, de Kort E, d'Haens EJ, Hulzebos CV, Huisman EJ, de Boode WP, Lopriore E, van der Bom JG; PlaNeT2 and MATISSE collaborators. Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death. Blood. 2019 Dec 26;134(26):2354-2360. doi: 10.1182/blood.2019000899.
PubMed 31697817Fustolo-Gunnink SF, Fijnvandraat K, Putter H, Ree IM, Caram-Deelder C, Andriessen P, d'Haens EJ, Hulzebos CV, Onland W, Kroon AA, Vijlbrief DC, Lopriore E, van der Bom JG. Dynamic prediction of bleeding risk in thrombocytopenic preterm neonates. Haematologica. 2019 Nov;104(11):2300-2306. doi: 10.3324/haematol.2018.208595. Epub 2019 Feb 28.
PubMed 30819913Hernan MA, Wang W, Leaf DE. Target Trial Emulation: A Framework for Causal Inference From Observational Data. JAMA. 2022 Dec 27;328(24):2446-2447. doi: 10.1001/jama.2022.21383.
PubMed 36508210Keogh RH, Van Geloven N. Prediction Under Interventions: Evaluation of Counterfactual Performance Using Longitudinal Observational Data. Epidemiology. 2024 May 1;35(3):329-339. doi: 10.1097/EDE.0000000000001713. Epub 2024 Apr 18.
PubMed 38630508van der Staaij H, Stanworth SJ, Fustolo-Gunnink SF. Prophylactic Platelet Transfusions: Why Less Is More. Clin Perinatol. 2023 Dec;50(4):775-792. doi: 10.1016/j.clp.2023.07.007. Epub 2023 Aug 31.
PubMed 37866847van Geloven N, Swanson SA, Ramspek CL, Luijken K, van Diepen M, Morris TP, Groenwold RHH, van Houwelingen HC, Putter H, le Cessie S. Prediction meets causal inference: the role of treatment in clinical prediction models. Eur J Epidemiol. 2020 Jul;35(7):619-630. doi: 10.1007/s10654-020-00636-1. Epub 2020 May 22.
PubMed 32445007
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Predictions Under Repeated Interventions: Estimating the Risk of Major Bleeding or Death With and Without Prophylactic Platelet Transfusion in Thrombocytopenic Neonates.
- ClinicalTrials.gov ID
- NCT06043050
- Acronym / sponsor ID
- PROSPECT / 22-3028
- Keywords
- Sequential prediction under interventions, Causal prediction, Hemorrhage, Neonate, Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Sanquin Research & Blood Bank Divisions, Amsterdam University Medical Center
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Sep 2023 (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.
Preterm neonates often receive platelet transfusions when their platelet count is low to prevent bleeding. However, it is currently unclear which infants benefit from such transfusions. A recent randomized controlled trial (PlaNeT-2/MATISSE trial) showed that the higher platelet count threshold for transfusion was associated with a higher risk of major bleeding or death. Current transfusion protocols are based only on platelet count thresholds. However, neonates with similar platelet counts may have different bleeding risks due to varying clinical conditions. There is an important unmet medical need to identify which neonates with low platelet counts (i.e., severe thrombocytopenia) will benefit from a transfusion. Ideally, clinicians would be able to repeatedly predict a neonate's risk of major bleeding or death with and without giving a platelet transfusion, taking into account the neonate's clinical condition at that particular time. Obtaining personalized risk estimates under specific treatment strategies, with updated predictions at each new treatment decision moment, is called 'sequential prediction under interventions'. The investigators set up an international multicenter observational cohort study to develop a model to predict major bleeding or death with and without platelet transfusion at any time point during the first week after the onset of severe thrombocytopenia. This model is designed to support platelet transfusion decisions in the NICU and may help clinicians balance the benefits and harms of platelet transfusion based on updated characteristics of the neonate at the time of prediction.
Detailed description
Main objective: To develop a sequential interventional prediction model to support transfusion decisions by predicting the risk of major bleeding or death with and without giving a platelet transfusion to neonates with severe thrombocytopenia (i.e., platelet count below 50x10^9/L), conditional on their characteristics present at the moment of prediction.
Study design: Multicenter international observational cohort study.
Study population: Neonates with a gestational age below 34 weeks and at least one platelet count below 50x10^9/L, admitted to a neonatal intensive care unit (NICU) between January 1st 2017 and January 1st 2022.
Main study endpoint: Major bleeding or mortality during NICU admission
Assessments: Only routine care data will be collected. This includes platelet counts and transfusions, cranial (head) ultrasounds and other information on bleeding, and multiple clinical variables.
Statistical analyses: Development of a sequential prediction model under interventions using the cloning-censoring-weighting approach with inverse probability weighting. Validation of the model in a separate cohort of preterm neonates with severe thrombocytopenia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with severe thrombocytopenia | – | Drug: PlateletsNeonates with a gestational age below 34 weeks and at least one platelet count below 50x10^9/L, who were admitted to a NICU between January 1st, 2017 and January 1st, 2022. |
Who may qualify
- Ages
- 22 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- Gestational age at birth <34 weeks;
- At least one platelet count <50x109/L;
- Admission to a participating tertiary care NICU, including postnatal transfers, between January 1st, 2017 and January 1st, 2022.
Key exclusion criteria (4 listed)
- A severe congenital malformation;
- 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);
- Only platelet counts <50x109/L in the context of exchange transfusion;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlateletsAlso: Platelet transfusionObservational data: all platelet transfusions recorded in routine care medical file data. | Drug | Neonates with severe thrombocytopenia |
Primary outcome
A composite of major bleeding or death during NICU admission is the primary outcome. Neonates who first had a major bleeding and then died reach the endpoint at the time of the major bleeding.
Time frame: From onset of severe thrombocytopenia until one week thereafter. The risk of major bleeding or death is predicted within 3 days and within 14 days from each moment of prediction during this time frame.
The investigators defined major bleeding as either one of the following: 1. Intraventricular hemorrhage (IVH) grade 3 or IVH of any grade in combination with parenchymal involvement (according to the Volpe grading system); 2. Parenchymal hemorrhage (without IVH) or cerebellar hemorrhage (>4 mm visible on cranial ultrasound, not if ≤4 mm visible on MRI only); 3. Pulmonary hemorrhage, defined as a fresh bleed from the trachea requiring intubation or ventilation, or a fresh bleed from the tube requiring increased ventilatory requirements; 4. Any type of severe hemorrhage, including gastrointestinal bleeding, if associated with hemodynamic instability (e.g., hypotension) and/or requiring one of the following interventions within 24h*: 1. Red blood cell transfusion 2. Volume boluses 3. Inotropes (either start of inotropes, or increased dose of current therapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 30387697Curley A, Stanworth SJ, Willoughby K, Fustolo-Gunnink SF, Venkatesh V, Hudson C, Deary A, Hodge R, Hopkins V, Lopez Santamaria B, Mora A, Llewelyn C, D'Amore A, Khan R, Onland W, Lopriore E, Fijnvandraat K, New H, Clarke P, Watts T; PlaNeT2 MATISSE Collaborators. Randomized Trial of Platelet-Transfusion Thresholds in Neonates. N Engl J Med. 2019 Jan 17;380(3):242-251. doi: 10.1056/NEJMoa1807320. Epub 2018 Nov 2.
- Background: PubMed 33738269Davenport P, Sola-Visner M. Hemostatic Challenges in Neonates. Front Pediatr. 2021 Mar 2;9:627715. doi: 10.3389/fped.2021.627715. eCollection 2021.
- Background: PubMed 38261320Davenport PE, Wood TR, Heagerty PJ, Sola-Visner MC, Juul SE, Patel RM. Platelet Transfusion and Death or Neurodevelopmental Impairment in Children Born Extremely Preterm. JAMA Netw Open. 2024 Jan 2;7(1):e2352394. doi: 10.1001/jamanetworkopen.2023.52394.
- Background: PubMed 31697817Fustolo-Gunnink SF, Fijnvandraat K, van Klaveren D, Stanworth SJ, Curley A, Onland W, Steyerberg EW, de Kort E, d'Haens EJ, Hulzebos CV, Huisman EJ, de Boode WP, Lopriore E, van der Bom JG; PlaNeT2 and MATISSE collaborators. Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death. Blood. 2019 Dec 26;134(26):2354-2360. doi: 10.1182/blood.2019000899.
- Background: PubMed 30819913Fustolo-Gunnink SF, Fijnvandraat K, Putter H, Ree IM, Caram-Deelder C, Andriessen P, d'Haens EJ, Hulzebos CV, Onland W, Kroon AA, Vijlbrief DC, Lopriore E, van der Bom JG. Dynamic prediction of bleeding risk in thrombocytopenic preterm neonates. Haematologica. 2019 Nov;104(11):2300-2306. doi: 10.3324/haematol.2018.208595. Epub 2019 Feb 28.
- Background: PubMed 36508210Hernan MA, Wang W, Leaf DE. Target Trial Emulation: A Framework for Causal Inference From Observational Data. JAMA. 2022 Dec 27;328(24):2446-2447. doi: 10.1001/jama.2022.21383.
- Background: PubMed 38630508Keogh RH, Van Geloven N. Prediction Under Interventions: Evaluation of Counterfactual Performance Using Longitudinal Observational Data. Epidemiology. 2024 May 1;35(3):329-339. doi: 10.1097/EDE.0000000000001713. Epub 2024 Apr 18.
- Background: PubMed 37866847van der Staaij H, Stanworth SJ, Fustolo-Gunnink SF. Prophylactic Platelet Transfusions: Why Less Is More. Clin Perinatol. 2023 Dec;50(4):775-792. doi: 10.1016/j.clp.2023.07.007. Epub 2023 Aug 31.
- Background: PubMed 32445007van Geloven N, Swanson SA, Ramspek CL, Luijken K, van Diepen M, Morris TP, Groenwold RHH, van Houwelingen HC, Putter H, le Cessie S. Prediction meets causal inference: the role of treatment in clinical prediction models. Eur J Epidemiol. 2020 Jul;35(7):619-630. doi: 10.1007/s10654-020-00636-1. Epub 2020 May 22.
- Individual participant dataSharing planned: No. Due to the sensitivity of the data, the underlying data sets will not be shared publicly due to ethical/privacy restrictions. However, all analyses will be documented, reproducible and available for audit. The data dictionary will be available upon request or as appendix in the manuscript. We might consider restricted access to the raw data in a repository when the target journal deems this necessary for publication. For future collaboration with the research partners or for data transfer/sharing, written agreements on data management, privacy, data ownership and intellectual properties will be made, such as a research collaboration agreement and data sharing agreement, and discussed with the support of Legal/Privacy/RDM experts where appropriate. In line with the Netherlands Code of Conduct for Research Integrity, raw and processed will be stored for a period of at least 10 years. The LUMC has long-term storage with back-up available for this.
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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.
Hilde van der Staaij, MD study director
Leiden University Medical Center and Sanquin Blood Supply Foundation
Johanna G van der Bom, MD/PhD/Prof principal investigator
Leiden University Medical Center
Camila Caram-Deelder, MSc/PhD principal investigator
Leiden University Medical Center
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Thrombocytopenia and Intraventricular Hemorrhage, run by Leiden University Medical Center at 12 sites in 3 countries.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of major bleeding or death during NICU admission is the primary outcome. Neonates who first had a major bleeding and then died reach the endpoint at the time of the major bleeding. (time frame: From onset of severe thrombocytopenia until one week thereafter. The risk of major bleeding or death is predicted within 3 days and within 14 days from each moment of prediction during this time frame.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043050, which also lists 9 linked publications.
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 9 Sep 2025.