oxIdative stress in late preterM and term newborns with Persistent pulmonAry hypertension in the neonatal intensive Care uniT (IMPACT-study)

oxIdative stress in late preterM and term newborns with Persistent pulmonAry hypertension in the neonatal intensive Care uniT (IMPACT-study) - IMPACT-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57289

Enrollment

Registered

2024-08-01

Start date

2025-03-22

Completion date

Unknown

Last updated

2026-03-23

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

Conditions

Persistent Pulmonary Hypertension of the Newborn

Interventions

Not applicable.&nbsp

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age at birth >= 34 weeks. 2. Treatment with oxygen and inhaled nitric oxide (iNO) in the NICU of the LUMC for PPHN.

Exclusion criteria

Exclusion criteria: 1. Congenital malformations that affect the ability to adequately oxygenate (e.g., cyanotic congenital heart defects and congenital diaphragmatic hernia). 2. No arterial line in place as part of standard care.

Design outcomes

Primary

Measure	Time frame
The main study parameters are oxidative stress levels, quantified by the concentration of 8-iso-PGF2a and malondialdehyde (MDA) in the plasma and urine.	—

Secondary

Measure	Time frame
Secondary parameters include the concentration and duration of supplemental oxygen therapy, and the occurrence of hyperoxemia and hypoxemia.	—

Countries

Netherlands

Contacts

Public ContactJ. Jager

Leids Universitair Medisch Centrum

IMPACT@lumc.nl+31 6 21981600

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026