Safety and efficacy of nadroparin in neonates: an observational study.

Safety and efficacy of nadroparin in neonates: an observational study. - SAFE-NEO

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56793

Enrollment

Registered

2024-01-19

Start date

2025-04-14

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis Blood cloth

Interventions

A national observational prospective study, conducted in 6 Neonatal Intensive Care Units/ Children’s Hospitals in the Netherlands.&nbsp

Eligibility

Inclusion criteria

Inclusion criteria: Neonates already receiving therapeutic or prophylactic nadroparin dosage as  part of their treatment.

Exclusion criteria

Exclusion criteria: •No informed consent •Major congenital malformations •Metabolic disorders •Previous cerebral bleeding •Neonates with any condition that, as judged by the investigator, would place  the neonate at increased risk of harm if he/she participated in the study.

Design outcomes

Primary

Measure	Time frame
Therapeutic nadroparin administration: To establish evidence-based therapeutic dosing regimens of nadroparin for extremely premature, premature and term neonates by means of objectification of the PK/PD of nadroparin during standard care. Prophylactic nadroparin administration: To establish evidence-based therapeutic dosing regimens of nadroparin for premature and term neonates by means of objectification of the PK/PD of nadroparin during standard care. premature and term neonates	—

Measure

Time frame

Therapeutic nadroparin administration: To establish evidence-based therapeutic dosing regimens of nadroparin for extremely premature, premature and term neonates by means of objectification of the PK/PD of nadroparin during standard care. Prophylactic nadroparin administration: To establish evidence-based therapeutic dosing regimens of nadroparin for premature and term neonates by means of objectification of the PK/PD of nadroparin during standard care. premature and term neonates

—

Secondary

Measure	Time frame
Therapeutic nadroparin administration: Secondary endpoint: 1. The incidence of complete thrombus resolution in relation to anti Xa levels within 3 months after the start of nadroparin treatment 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin Prophylactic nadroparin administration: Secondary endpoint: 1. The incidence of new or recurrent thrombosis in relation to anti Xa levels during treatment with nadroparin 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin	—

Measure

Time frame

Therapeutic nadroparin administration: Secondary endpoint: 1. The incidence of complete thrombus resolution in relation to anti Xa levels within 3 months after the start of nadroparin treatment 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin Prophylactic nadroparin administration: Secondary endpoint: 1. The incidence of new or recurrent thrombosis in relation to anti Xa levels during treatment with nadroparin 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin

—

Countries

Netherlands

Contacts

Public ContactI.L.M. Klaassen

Amsterdam UMC

safe_neo@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)