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

NCT ID: NCT06729398

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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

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

Keywords

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Near Infrared Spectroscopy Intraventricular hemorrhage Periventricular leukomalacia Preterm neonates Very Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NIRS and SafeboosC group

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

Group Type EXPERIMENTAL

NIRS

Intervention Type DEVICE

NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours

SafeboosC

Intervention Type OTHER

SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.

Control group

Standard procedure and monitoring device are used for every participant in the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NIRS

NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours

Intervention Type DEVICE

SafeboosC

SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lily Rundjan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Cipto Mangunkusumo General Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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623/UN2.F1/ETIK/2016

Identifier Type: -

Identifier Source: org_study_id