To investigate oxidative stress levels in the plasma and urine of late preterm and term newborns treated for PPHN in the NICU.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Neonatal respiratory disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are oxidative stress levels, quantified by the
concentration of 8-iso-PGF2α and malondialdehyde (MDA) in the plasma and urine.
Secondary outcome
Secondary parameters include the concentration and duration of supplemental
oxygen therapy, and the occurrence of hyperoxemia and hypoxemia.
Background summary
Persistent pulmonary hypertension of the newborn (PPHN) is a complication
during neonatal transition characterized by sustained elevation in pulmonary
vascular resistance (PVR), primarily affecting late preterm and term newborns.
Treatment in the NICU often involves high concentrations of supplemental oxygen
and inhaled nitric oxide (iNO) to reduce PVR and improve oxygenation. It has
been well established that high concentrations of supplemental oxygen during
resuscitation of late preterm and term newborns are harmful, but little is
known about the potential harmful effects of liberal oxygen use once these
newborns are admitted to the NICU.
Study objective
To investigate oxidative stress levels in the plasma and urine of late preterm
and term newborns treated for PPHN in the NICU.
Study design
Single center, prospective, observational cohort study.
Study burden and risks
The risks associated with participating in the study can be considered
negligible, and the burden can be considered minimal as blood and urine
sampling are part of standard care in the NICU, eliminating the need for
additional punctures. The maximum total additional volume of blood drawn for
this study is less than the amount collected on the first day for standard care
analyses. The urine that is sampled would otherwise be discarded. Due to the
observational nature of this study, the included newborns will not directly
benefit from participating in the study. However, previous research indicates
that helping future patients is a significant factor motivating parents to
consent to their newborns' participation in neonatal studies. The study
population was selected because newborns with PPHN are unique among late
preterm and term newborns in that they need extended periods of high
concentrations of oxygen therapy. Unlike preterm newborns, there are no
guidelines for oxygen use in these newborns, placing them at a particularly
high risk of oxidative stress.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
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
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87541.058.24 |