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Needle-Free anemia detection for fragile newborns?

NCT ID NCT07788703

Diagnosis Sponsor: University of Malaya Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive sensor placed on the skin can accurately measure hemoglobin levels in infants in the neonatal intensive care unit (NICU). The sensor uses light to estimate hemoglobin without any needle sticks, which could reduce pain and blood loss in these vulnerable babies. Researchers will compare the sensor's readings to standard lab tests taken during routine care to see how well they agree and if the sensor can reliably detect anemia. The goal is to find a gentler way to monitor anemia in newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-invasive spectrophotometric hemoglobin measurement using the Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology
What this could lead to
If successful, this could provide a painless, needle-free way to monitor anemia in fragile newborns, reducing blood loss and distress.
What could go wrong
The study is small (30 infants) and early, so accuracy may vary. Skin tone, perfusion, and other factors could affect readings, and it may not replace lab tests in all cases.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants (preterm or term) admitted to the Neonatal Intensive Care Unit. * Gestational age ≥ 24 weeks at birth. * Admitted to NICU during the study period. * Clinical indication for laboratory haemoglobin measurement as part of routine care. * Written informed consent obtained from parent or legal guardian. Exclusion Criteria: * Known or suspected haemoglobinopathy. * Cyanotic congenital heart disease. * Significant skin integrity issues at the proposed sensor site (e.g. burns, severe dermatitis, wounds, oedema, or medical devices preventing probe placement). * Conditions likely to cause unreliable peripheral perfusion at the discretion of the attending clinician. * Severe hypothermia (below 32°C) or hyperthermia (more than 40°C). * Prolonged capillary refill time indicating poor peripheral perfusion.

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Conditions

The condition(s) this trial relates to.

anemia neonatal anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Malaya Medical Center

    Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

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