Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT06043050
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Weeks
Maximum Age:
34 Weeks
Study:
NCT06043050
Study Brief:
Protocol Section:
NCT06043050