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Neurodevelopmental Outcome After Fetal Neonatal AlloImmune Thrombocytopenia

NCT04529382 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2020-08-27

No results posted yet for this study

Summary

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. This complication can be prevented by weekly administration of intravenous immunoglobulin (IVIg) to the mother during pregnancy. Knowledge on long-term development of FNAIT survivors with or without IVIg treatment is very limited but an important subject in the counselling of parents of newly diagnosed cases. To evaluate the long-term neurodevelopmental outcome in two groups of children with FNAIT will be asked to participate in our study in an outpatient clinic setting.

Conditions

  • Fetal and Neonatal Alloimmune Thrombocytopenia
  • Long Term Adverse Effects
  • Neurodevelopmental Abnormality
  • Intravenous Immunoglobulin Adverse Reaction

Interventions

DIAGNOSTIC_TEST

Cognitive testing (Bayley III, WPPSI III and WISC V)

Parents and children will be invited to come for an outpatient clinic visit where cognitive testing and neurologic examination will be performed. In addition to this parents will be asked to fill in questionnaires, provide latest school results and medical files will be requested from treating physicians.

Sponsors & Collaborators

  • Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Enrico Lopriore, Prof. MD PhD · Department of Neonatology, Leiden University Medical Center

  • Masja de Haas, Prof. MD PhD · Stichting Sanquin Bloedvoorziening

Eligibility

Min Age
18 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2020-12-17
Completion
2021-12-17

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529382 on ClinicalTrials.gov