Monitoring Outcome in Neonatal Thrombocytopenia (MONET)
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|ClinicalTrials.gov Identifier: NCT03110887|
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : August 15, 2017
Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a major hemorrhage. In an attempt to avert this severe complication various preventive measures have been implemented. One of these is the transfusion of platelets to premature neonates with low platelet counts. However, this practice is not supported by scientific evidence. Most neonates with low platelet counts never experience a major bleeding and platelet transfusions may carry risks of volume overload or infection. Therefore, it is important to treat only those patients that truly benefit from this intervention. We urgently need a scientifically based tool to predict which premature neonates are at risk for major bleeding. A few prediction models do exist, but these only allow assessment of bleeding risk at baseline, and do not correct for changes in clinical status during the admission period. We believe that adding this feature to our prediction model will significantly improve our ability to predict bleeding. The prediction model will also be helpful in developing individualized transfusion guidelines as it helps us to predict which neonates would benefit from prophylactic platelet transfusions.
Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with low platelet counts.
Study design: retrospective observational cohort study.
Study population: neonates with a gestational age at birth of < 34 weeks admitted to a neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be included.
Assessments: only data generated through standard care will be collected. This includes platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and multiple clinical variables.
Main study endpoint: major bleeding during admission
Statistical analyses: dynamic prediction model using landmarking.
|Condition or disease|
|Neonatal Thrombocytopenia Intraventricular Hemorrhage Platelet Transfusion|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||700 participants|
|Official Title:||Monitoring Outcome in Neonatal Thrombocytopenia|
|Actual Study Start Date :||November 20, 2015|
|Actual Primary Completion Date :||October 21, 2016|
|Actual Study Completion Date :||November 9, 2016|
Preterm neonate with thrombocytopenia
Preterm neonates (GA<34 weeks) with severe thrombocytopenia
- Major hemorrhage [ Time Frame: T0 = time of first platelet count <50. End of study = major bleed, death or discharge. Datacollection between 01-01-2010 and 31-12-2014 ]Any type of major bleeding (IVH, pulmonary hemorrhage, gastro-intestinal hemorrhage, etc, according to prespecified definitions)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110887
|Principal Investigator:||Karin Fijnvandraat, MD PhD prof||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Enrico Lopriore, MD PhD prof||Leiden University Medical Center|
|Principal Investigator:||Anske van der Bom, MD PhD prof||Sanquin Blood Supply Foundation, department of clinical transfusion research, Leiden, the Netherlands|