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

NCT07788703 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2026219-16355ID RSCH ID-26-05390-RJH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the agreement between non-invasive SpHb and laboratory reference total haemoglobin (tHb)?
2. 2.How accurately can non-invasive SpHb detect clinically significant laboratory anaemia (Hb \< 10g/dL)?
3. 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.
4. 4.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.
5. 5.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

Anemia

Keywords

neonatal anemia; spectrophotometry hemoglobin; anemia of prematurity; neonatal intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sensitivity and specificity of SpHb for detection of anaemia

  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

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

• Regression coefficient for perfusion index and SpHb-tHb measurement difference

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

• Regression coefficient for gestational age and SpHb-tHb measurement difference

  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

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

Study Arms (1)

SpHb

EXPERIMENTAL

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

Interventions

Spectrophotometry hemoglobin DEVICE

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.

Also known as: Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology

SpHb

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead
• Universiti Sains Islam Malaysia: collaborator

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (6)

• 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.

  PMID: 39806708 BACKGROUND

• 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.

  PMID: 25742288 BACKGROUND

• 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.

  PMID: 35906313 BACKGROUND

• 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.

  PMID: 26702617 BACKGROUND

• 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.

  PMID: 21545905 BACKGROUND

• 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.

  PMID: 16352948 BACKGROUND

MeSH Terms

Conditions

Anemia; Anemia, Neonatal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd

CONTACT

+60132134616; aliyyahkhuzaini@usim.edu.my

Azanna Ahmad Kamar, MBBS, MRCPCH

CONTACT

+603-79492065; azanna@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Neonatology

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)