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NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU)

NCT07788703 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-26

No results posted yet for this study

Summary

The goal of this study is to evaluate the diagnostic performance and feasibility of non-invasive spectrophotometric haemoglobin (SpHb) measurement for detecting anaemia in infants admitted to the Neonatal Intensive Care Unit (NICU). The main questions it aims to answer are:

1. What is the agreement between non-invasive SpHb and laboratory reference total haemoglobin (tHb)?
2. How accurately can non-invasive SpHb detect clinically significant laboratory anaemia (Hb \< 10g/dL)?
3. What is the feasibility (success rate and time-to-reading) and what physiological factors (e.g., perfusion index) moderate measurement accuracy in NICU infants? Researchers will compare non-invasive continuous SpHb readings against routine invasive laboratory haemoglobin values (tHb) obtained during standard clinical care from the same clinical encounter.

Participants will:

1. Have a non-invasive optical sensor applied to an approved peripheral site (e.g., foot or palm) to record an SpHb reading whenever routine blood sampling is required by their attending clinician.
2. Undergo standard routine blood sampling (venous, arterial, or capillary) for laboratory haemoglobin testing as part of usual clinical care, with no extra blood drawn for research purposes.

Conditions

Interventions

DEVICE

Spectrophotometry hemoglobin

1. The index test utilizes multi-wavelength spectrophotometry (Masimo Radical-7® with rainbow® sensors) applied topically to peripheral tissue (e.g., foot, palm, or digit). It requires zero skin punctures, creates no additional iatrogenic blood loss, and causes no pain or distress to fragile neonates. 2. Unlike standard diagnostic studies that require dedicated blood sampling for research, this protocol collects reference laboratory total haemoglobin (tHb) strictly when clinically indicated for routine care. No extra phlebotomy is performed solely for the study. 3. Non-invasive SpHb measurements are acquired within a strict 5-minute window of routine clinical blood sampling to eliminate physiological variability over time and ensure paired accuracy assessment.

Sponsors & Collaborators

  • Universiti Sains Islam Malaysia

    collaborator OTHER

  • University of Malaya

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788703 on ClinicalTrials.gov