Brain oxygen monitor shows promise in protecting preterm infants from injury
NCT ID NCT06729398
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether using a brain oxygen monitor (cerebral NIRS) along with a treatment guideline could prevent brain injury in very low birth weight preterm infants. 129 babies born at 32 weeks or earlier or weighing under 1500 grams took part. The monitor was placed on the baby's head for the first 72 hours of life, and doctors followed a guideline to keep oxygen levels normal. The goal was to see if this approach reduced brain bleeding or white matter damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Near Infrared Spectroscopy (NIRS) device and SafeboosC treatment guideline
- What this could lead to
- If effective, this monitoring approach could help prevent brain injury and reduce mortality in fragile preterm infants.
- What could go wrong
- This is a single completed trial with 129 participants, so results may not apply broadly. The device only monitors oxygen levels and does not directly treat injury.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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129 people
The number who actually took part.
- Started
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May 2017
- Finished
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May 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 days and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dr. Cipto Mangunkusumo General Hospital
Jakarta, Indonesia
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