The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants (NCT06729398) | Clinical Trial Compass
CompletedNot Applicable
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
Indonesia129 participantsStarted 2017-05-01
Plain-language 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.
Who can participate
Age range
3 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — can you tell me if the results are available yet, and what they showed about whether using NIRS brain monitoring in the first 72 hours actually helped reduce brain injury in very premature babies?
2My baby is very low birth weight — does our hospital currently use cerebral NIRS monitoring as a standard part of care, or is that something only available in research settings like this trial?
3The trial focused on two serious outcomes — brain bleeds and periventricular leukomalacia — can you explain which of these our baby is most at risk for, and how closely they'll be monitored in the first 72 hours?
4Since this trial wasn't testing a drug but rather a monitoring approach, what does the evidence from completed studies like this one suggest about whether continuous brain oxygen monitoring changes the decisions doctors make in real time?
5If this trial's results are promising, how soon might NIRS-guided brain monitoring become a routine part of care for very premature babies at this hospital, and is there anything similar currently available for our baby?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.