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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

72 hours preterm brain injury

Timeframe: 72 hours

Trial details

NCT IDNCT06729398

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-01

View on ClinicalTrials.gov More Neonatal Cerebral Leukomalacia trials