Recruiting

Observational Study

Sponsor:

Karolinska Institutet

Code:

NCT04598750

Conditions

Neonatal Thrombocytopenia

Bleeding

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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 thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.

Conditions

Neonatal Thrombocytopenia

Bleeding

Study ID

NCT04598750

Start date

Jun 15, 2021

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have a gestational age <32 weeks and a birth weight ≥500 grams;
  • Have a platelet count <100 x 109/L; and
  • Have a parent/guardian willing to provide written informed consent.

Exclusion Criteria:

  • Are not expected to survive for >24 hours by the Attending Neonatologist;
  • Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • NeoBAT score [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Emöke Deschmann, MD, PhD

+46 73 539 5575emoke.deschmann@regionstockholm.se

Martha Sola-Visner, MD

617-919-4845martha.sola-visner@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Martha Sola-Visner, MD

martha.sola-visner@childrens.harvard.edu

More Information

Sponsor

Karolinska Institutet

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Karolinska Institutet on 2024-10-09.