NCT06729398

The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants

The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

Summary

This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm neonates. Each experimental and control groups consists of at least 30 participants, and only the experimental group uses cerebral NIRS and a treatment guideline.

Detailed description

There are still high number of preterm mortality and morbidity in Indonesia. Preterm infants are susceptible to get brain injury due to hemodynamic changes and loss of cerebral autoregulation. Some studies showed that fluctuated changes of brain blood flow caused intraventricular hemorrhage (IVH), and the decreasing of brain blood flow lead to a hypoxic- ischemic state which had role for periventricular leucomalacia (PVL) formation. These result a long term neurologic deficit outcome such as cerebral palsy and cognitive impairment. The standard measures that mainly performed in the NICU were systemic arterial oxygenation and mean arterial blood pressure. There is not yet routine procedure to measure the brain perfusion and oxygenation in Indonesia. Cerebral Near Infrared Spectroscopy (NIRS) is an invasive tool that continuously measures brain tissue hemoglobin oxygen saturation (rStO2) and determines cerebral circulation. The mechanism of NIRS is based on the light absorption by the hemoglobin, which the value reflects the ratio of oxygenated hemoglobin concentration to total hemoglobin in the penetrated tissue. To prevent the permanent neurological damage from hypoxia or hyperoxia events, the investigators use cerebral NIRS combined with SafeboosC (Safeguarding the brain of our smallest children) treatment guidelines. The research programme SafeboosC phase II trial hypothesizes that the burden of hypoxia and hyperoxia can be reduced among preterm. The investigators recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups after a written informed consent was approved by the parents. One group uses cerebral NIRS as a monitoring device and performed a treatment guideline to maintain a normal value of rStO2. The other group receives standard treatment without placement of cerebral NIRS. A routine brain ultrasonography is done in both groups to evaluate brain injury (PVL or IVH). Significance testing is done by Chi-square or Fisher's exact test as needed.

Conditions

• Neonatal Cerebral Leukomalacia
• Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
• Neonatal Mortality

Interventions

Type	Name	Description
DEVICE	NIRS	NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours
OTHER	SafeboosC	SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2024-12-11
• Last updated: 2025-11-12

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated device study