Clinical trials: Neonatal Thrombocytopenia
Thrombocytopenia, Neonatal Alloimmune
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Trial name
- FREESIA-3 (NCT06533098)
- Testing
- Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone
- Where
- 32 sites in United States, Austria and 7 more
- Volunteers
- 50 people
- Sponsor
- Janssen Research & Development, LLC
Thrombocytopenia, Neonatal Thrombocytopenia
Neonatal Thrombocytopenia in the NICU
This prospective cohort study aims to determine the frequency, severity, and clinical outcome of thrombocytopenia among neonates admitted to the neonatal intensive care unit.
- Trial name
- NCT07882342
- Volunteers
- 120 people
- Sponsor
- Assiut University
Thrombocytopenia, Neonatal Alloimmune
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Trial name
- FREESIA-1 (NCT06449651)
- Testing
- Nipocalimab
- Where
- 21 sites in Belgium, Brazil and 10 more
- Volunteers
- 39 people
- Sponsor
- Janssen Research & Development, LLC
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Fetal and Neonatal Alloimmune Thrombocytopenia
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in…
- Trial name
- NCT05345561
- Testing
- Clinical data collection
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 14,390 people, healthy volunteers welcome
- Sponsor
- Rallybio
Fetal and Neonatal Alloimmune Thrombocytopenia
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
- Trial name
- NCT06435845
- Testing
- Anti-(integrin beta-3) human monoclonal antibody
- Where
- 3 sites in Netherlands, Norway and 1 more
- Volunteers
- 1 people
- Sponsor
- Rallybio
Neonatal Thrombocytopenia, Intraventricular Hemorrhage
PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia
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.
- Conditions
- Neonatal Thrombocytopenia, Intraventricular Hemorrhage, Platelet Transfusion
- Trial name
- PROSPECT (NCT06043050)
- Testing
- Platelets
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 1,042 people
- Sponsor
- Leiden University Medical Center
Neonatal Thrombocytopenia, Bleeding
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in…
- Trial name
- NEOHAT-2 (NCT04598750)
- Where
- 8 sites in United States, Netherlands and 1 more
- Volunteers
- 250 people
- Sponsor
- Karolinska Institutet
Neonatal Thrombocytopenia
Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates
Parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent to enter the study. For the purposes of the study, thrombocytopenia will be defined as a platelet count <60,000/uL or a platelet count…
- Trial name
- NCT02802982
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Boston Children's Hospital
Neonatal Thrombocytopenia
Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
This is a prospective observational study that was designed with the following two Specific Aims: 1. To determine whether the Immature Platelet Fraction percentage (IPF%) and the Immature Platelet Count (IPC) are better…
- Trial name
- NCT03848923
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Boston Children's Hospital
Neonatal Thrombocytopenia Isoimmunization Maternal-fetal
Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis
Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother.
- Trial name
- NCT02899598
- Testing
- Extra blood draw samples, extra amniotic fluid samples
- Where
- France
- Sponsor
- Assistance Publique Hopitaux De Marseille
Fetal and Neonatal Alloimmune Thrombocytopenia
Towards Routine HPA-screening In Pregnancy to Prevent FNAIT
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is the most common cause of severe thrombocytopenia in otherwise healthy born neonates.
- Trial name
- HIP (NCT04067375)
- Testing
- Clinical data collection.
- Where
- Netherlands
- Volunteers
- 3,660 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Fetal and Neonatal Alloimmune Thrombocytopenia, Long Term Adverse Effects
Neurodevelopmental Outcome After Fetal Neonatal AlloImmune Thrombocytopenia
Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a disease caused by allo-immunisation during pregnancy. If left untreated, FNAIT can lead to severe fetal intracranial haemorrhage.
- Conditions
- Fetal and Neonatal Alloimmune Thrombocytopenia, Long Term Adverse Effects, Neurodevelopmental Abnormality, Intravenous Immunoglobulin Adverse Reaction
- Trial name
- NOFNAIT (NCT04529382)
- Testing
- Cognitive testing (Bayley III, WPPSI III and WISC V)
- Where
- Netherlands
- Volunteers
- 78 people
- Sponsor
- Leiden University Medical Center
Fetal and Neonatal Alloimmune Thrombocytopenia
Kinetics of Blood Platelets Transfused to Healthy Subjects
The current phase 0 trial is preceding the phase 1/2 trial of a newly developed drug, NAITgam, for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) - a rare, but potentially very severe bleeding condition…
- Trial name
- NCT03561909
- Testing
- Platelet transfusion
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Prophylix Pharma AS
Thrombocytopenia Neonatal
Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit
Thrombocytopenia is diagnosed when platelet count is lower than 150,000 U/L, it is a common hemostatic problem in neonatal intensive care units According to platelets count, it is classified into mild thrombocytopenia with…
- Trial name
- NCT03448952
- Volunteers
- 150 people
- Sponsor
- Sylvia Elzek
Maternal-Fetal Exchange
Maternal High Blood Pressure and Newborn's Blood Profile
Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity.
- Trial name
- MPIHHPN (NCT03265704)
- Testing
- AGA - Control group, SGA - Control group, AGA-PIH Study group
- Where
- Romania
- Volunteers
- 6,108 people
- Sponsor
- Romanian Society of Anesthesia and Intensive Care
Neonatal Thrombocytopenia, Intraventricular Hemorrhage
Monitoring Outcome in Neonatal Thrombocytopenia
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.
- Conditions
- Neonatal Thrombocytopenia, Intraventricular Hemorrhage, Platelet Transfusion
- Trial name
- MONET (NCT03110887)
- Volunteers
- 700 people
- Sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Neonatal Alloimmune Thrombocytopenia
Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an appropriate clinical screening procedure
- Trial name
- NCT02934906
- Testing
- Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion
- Volunteers
- 55,497 people, healthy volunteers welcome
- Sponsor
- Xinqiao Hospital of Chongqing