Neonatal Cerebral LeukomalaciaNCT06729398
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
A study testing NIRS and SafeboosC in people with Neonatal Cerebral Leukomalacia and Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, Neonatal Mortality
- What is being tested?
- NIRS and SafeboosC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonates born in dr. Cipto Mangunkusumo Hospital and admitted in the neonatal intensive care unit
- Gestational age ≤ 32 weeks and/or birth weight ≤ 1500grams
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- NIRS, SafeboosC
- Keywords
- Near Infrared Spectroscopy, Intraventricular hemorrhage, Periventricular leukomalacia, Preterm neonates, Very Low Birth Weight
- Medical subject headings
- Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours
SafeboosCOther
SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.
| Study group | Role | What they receive |
|---|---|---|
| NIRS and SafeboosC group | Experimental | 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. Receives: Device: NIRS; Other: SafeboosC |
| Control group | No intervention | Standard procedure and monitoring device are used for every participant in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
72 hours preterm brain injury
Brain ultrasonography at 72 hours of age is assessed by pediatric radiology specialist. Brain injury is positive when there are intraventricular or periventricular leukomalacia findings in the brain ultrasonography result.
Measured: 72 hours
Secondary outcomes (1)
Mortality rates
Very low birth weight related mortality rates
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 May 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Cerebral LeukomalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lily Rundjan, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729398
- Sponsor's protocol ID
- 623/UN2.F1/ETIK/2016
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data were confidential. Access were only given if the purposes is clear
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06729398
- Acronym / sponsor ID
- 623/UN2.F1/ETIK/2016
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRS and SafeboosC group | Experimental | Device: NIRS, Other: SafeboosCNIRS 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. |
| Control group | No intervention | –Standard procedure and monitoring device are used for every participant in the control group. |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSNIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours | Device | NIRS and SafeboosC group |
| SafeboosCSafeboosC treatment guideline is used to maintain normal value of cerebral rStO2. | Other | NIRS and SafeboosC group |
Primary outcome
72 hours preterm brain injury
Time frame: 72 hours
Brain ultrasonography at 72 hours of age is assessed by pediatric radiology specialist. Brain injury is positive when there are intraventricular or periventricular leukomalacia findings in the brain ultrasonography result.
1 secondary outcome
Mortality rates
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: Undecided. Data were confidential. Access were only given if the purposes is clear
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS and SafeboosC in people with Neonatal Cerebral Leukomalacia and Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
72 hours preterm brain injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.