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NCT Number: NCT07788703

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

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.

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Key information

Conditions

Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Center

Kuala Lumpur, 50603, Malaysia

Location contact

Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd

CONTACT

[email protected]

+60132134616

Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd

PRINCIPAL_INVESTIGATOR

Azanna Ahmad Kamar, MBBS, MRCPCH

SUB_INVESTIGATOR

Minn Yin Choo, MBBS, MMed, MRCPCH

CONTACT

[email protected]

+603-79492065

Minn Yin Choo, MBBS, MMed, MRCPCH

SUB_INVESTIGATOR

Tengku Amatullah Madeehah Tengku Mohd, MBChB, MSc, MPH, DrPH

SUB_INVESTIGATOR

About this study

What is the purpose of this study?

This study aims to find out how accurate a non-invasive device (SpHb) is in measuring haemoglobin (red blood cells) levels in babies admitted to the NICU. The study involves the use of the Masimo SpHb® (Spectrophotometric Hemoglobin), a non-invasive monitoring device currently used in clinical settings. The device is handheld and connected to a computer/tablet for recording measurements. It will be placed on the child's skin to measure the child's hemoglobin. The procedure does not involve needles, radiation, or painful interventions.

Why is this study important?

Babies in NICU often have anemia, where their red blood cells level is low. To monitor this condition, babies often need repeated blood tests, which can cause pain and blood loss. This study may help reduce unnecessary blood sampling in the future.

What type of study is this?

This is an observational study. We will compare readings from a non-invasive device with routine blood test results.

What is the procedure that is being tested? A device called Masimo SpHb® is placed on the baby's skin to measure haemoglobin using light. No blood is taken for this measurement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spectrophotometry hemoglobin

Device
  • 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.
  • 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.
  • 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.

Other names: Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology

Primary outcomes

  1. Agreement between non-invasive SpHb and laboratory haemoglobin measurements

    Time frame: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age

    Agreement between SpHb and laboratory haemoglobin will be assessed using Bland-Altman analysis, including mean bias and 95% limits of agreement.

    Unit of measure:

    g/dL

Secondary outcomes

  1. Sensitivity and specificity of SpHb for detection of anaemia

    Time frame: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age

    Sensitivity and specificity of SpHb for detecting anaemia, using laboratory haemoglobin as the reference standard. Anaemia will be defined according to the pre-specified haemoglobin threshold appropriate for the infant's gestational/postnatal age.

    Unit of measure:

    Percentage of participants

  2. Agreement between changes in SpHb and changes in laboratory haemoglobin over time

    Time frame: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age

    Description:

    The ability of serial SpHb measurements to detect changes in haemoglobin concentration over time will be assessed by comparing changes in SpHb with corresponding changes in laboratory haemoglobin measurements.

    Unit of measure:

    g/dL

  3. Regression coefficient for perfusion index and SpHb-tHb measurement difference

    Time frame: From enrollment through NICU discharge (up to 44 weeks postmenstrual age).

    Regression coefficient (β) and 95% confidence interval for perfusion index (measured by pulse co-oximeter perfusion index display, %) as a predictor of SpHb-tHb measurement difference, from a mixed-effects linear regression model with random intercept per infant.

    Unit of Measure: Regression coefficient (β) per 1% change in perfusion index

  4. Regression coefficient for gestational age and SpHb-tHb measurement difference

    Time frame: Gestational age recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).

    Regression coefficient (β) and 95% confidence interval for gestational age at birth (recorded in completed weeks from obstetric dating, per medical records) as a predictor of SpHb-tHb measurement difference, from a mixed-effects linear regression model with random intercept per infant.

    Unit of Measure: Regression coefficient (β) per completed week of gestational age

  5. Regression coefficient for birth weight and SpHb-tHb measurement difference

    Time frame: Birth weight recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).

    Regression coefficient (β) and 95% confidence interval for birth weight (recorded in grams at delivery, per medical records) as a predictor of SpHb-tHb measurement difference, from a mixed-effects linear regression model with random intercept per infant.

    Unit of Measure: Regression coefficient (β) per 100 grams of birth weight

  6. Regression coefficient for phototherapy and SpHb-tHb measurement difference

    Time frame: Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).

    Regression coefficient (β) and 95% confidence interval for concurrent phototherapy use (yes/no, recorded from NICU treatment records at the time of each paired measurement) as a predictor of SpHb-tHb measurement difference, from a mixed-effects linear regression model with random intercept per infant.

    Unit of Measure: Regression coefficient (β) for phototherapy exposure (on vs off)

Study contacts

Contact information is provided by the study sponsor or research team.

Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd

CONTACT

[email protected]

+60132134616

Azanna Ahmad Kamar, MBBS, MRCPCH

CONTACT

[email protected]

+603-79492065

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Universiti Sains Islam Malaysia

Registry information

Official study title

Validation of Non-invasive Spectrophotometric Haemoglobin (SpHb) Measurement for Detection of Anaemia and Observation of Trends in Infants Admitted to the Neonatal Intensive Care Unit (NICU): A Prospective Diagnostic Accuracy Study.

Acronym: NeoSpHb

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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