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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia
• Intervention / Treatment: Device: Spectrophotometry hemoglobin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd; Phone Number: +60132134616; Email: aliyyahkhuzaini@usim.edu.my
• Study Contact Backup: Name: Azanna Ahmad Kamar, MBBS, MRCPCH; Phone Number: +603-79492065; Email: azanna@um.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
      • University Malaya Medical Center
      • Contact: Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd; Phone Number: +60132134616; Email: aliyyahkhuzaini@usim.edu.my
      • Contact: Minn Yin Choo, MBBS, MMed, MRCPCH; Phone Number: +603-79492065; Email: minnyin@ummc.edu.my
      • Principal Investigator: Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
      • Sub-Investigator: Minn Yin Choo, MBBS, MMed, MRCPCH
      • Sub-Investigator: Azanna Ahmad Kamar, MBBS, MRCPCH
      • Sub-Investigator: Tengku Amatullah Madeehah Tengku Mohd, MBChB, MSc, MPH, DrPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SpHb; Infants admitted to the NICU will undergo non-invasive SpHb measurement, with results compared against laboratory haemoglobin values obtained as part of routine clinical care.

Device: Spectrophotometry hemoglobin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between non-invasive SpHb and laboratory haemoglobin measurements	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	During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of SpHb for detection of anaemia	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	During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
Agreement between changes in SpHb and changes in laboratory haemoglobin over time	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	During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
Regression coefficient for perfusion index and SpHb-tHb measurement difference	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	From enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Regression coefficient for gestational age and SpHb-tHb measurement difference	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	Gestational age recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Regression coefficient for birth weight and SpHb-tHb measurement difference	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	Birth weight recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Regression coefficient for phototherapy and SpHb-tHb measurement difference	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)	Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: Universiti Sains Islam Malaysia

Publications and helpful links

General Publications

• Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
• Nicholas C, George R, Sardesai S, Durand M, Ramanathan R, Cayabyab R. Validation of noninvasive hemoglobin measurement by pulse co-oximeter in newborn infants. J Perinatol. 2015 Aug;35(8):617-20. doi: 10.1038/jp.2015.12. Epub 2015 Mar 5.
• Saengnipanthkul S, Tawiangnan C, Sirikarn P, Supasai S, Sitthikarnkha P, Techasatian L, Uppala R. Accuracy of noninvasive total haemoglobin measurement for detecting anaemia in infants: a cross-sectional study in a well-child care clinic, Khon Kaen, Thailand. BMJ Open. 2024 Dec 30;14(12):e083356. doi: 10.1136/bmjopen-2023-083356.
• Arai Y, Shoji H, Awata K, Inage E, Ikuse T, Shimizu T. Evaluation of the use of non-invasive hemoglobin measurement in early childhood. Pediatr Res. 2023 Mar;93(4):1036-1040. doi: 10.1038/s41390-022-02204-7. Epub 2022 Jul 29.
• Hsu DP, French AJ, Madson SL, Palmer JM, Gidvani-Diaz V. Evaluation of a Noninvasive Hemoglobin Measurement Device to Screen for Anemia in Infancy. Matern Child Health J. 2016 Apr;20(4):827-32. doi: 10.1007/s10995-015-1913-9.
• Noiri E, Kobayashi N, Takamura Y, Iijima T, Takagi T, Doi K, Nakao A, Yamamoto T, Takeda S, Fujita T. Pulse total-hemoglobinometer provides accurate noninvasive monitoring. Crit Care Med. 2005 Dec;33(12):2831-5. doi: 10.1097/01.ccm.0000190430.96750.51.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 14, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: neonatal intensive care unit; neonatal anemia; anemia of prematurity; spectrophotometry hemoglobin
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Hematologic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia; Anemia, Neonatal
• Other Study ID Numbers: 2026219-16355; ID RSCH ID-26-05390-RJH (Registry Identifier: National Medical Research Registry, Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To safeguard participant confidentiality and privacy, individual participant-level data will not be made publicly available. Final study findings will be published in aggregate format only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes