Clinical trial NCT06729398: The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
Official title: The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Cerebral Leukomalacia
Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
Neonatal Mortality
Keywords: Near Infrared Spectroscopy
Intraventricular hemorrhage
Periventricular leukomalacia
Preterm neonates
Very Low Birth Weight
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 129
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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, we 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. We 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.

Eligibility criteria: * Inclusion Criteria:

  * Neonates born in dr. Cipto Mangunkusumo Hospital and admitted in the neonatal intensive care unit
  * Gestational age ≤ 32 weeks and/or birth weight ≤ 1500grams
* Exclusion Criteria:

  * Parents refuse to participate
  * Participants who are not able to use cerebral NIRS in the first 3 hours of life
  * Participants with congenital malformation and cerebral complications during delivery
  * Participants who are diagnosed with IVH/PVL in the first 3 hours of life (confirmed with brain ultrasonography examination and assessed by radiology pediatric specialist)

Primary outcomes:
measure: 72 hours preterm brain injury
timeFrame: 72 hours
Secondary outcomes:
measure: Mortality rates
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo General Hospital
Study officials:
References: