AnemiaNeoSpHbNCT07788703
NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU)
A study testing Spectrophotometry hemoglobin in people with Anemia, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- Spectrophotometry hemoglobin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 50603
Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd, +60132134616, aliyyahkhuzaini@usim.edu.my
Minn Yin Choo, MBBS, MMed, MRCPCH, +603-79492065, minnyin@ummc.edu.my
About this study
Official 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.
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:
- What is the agreement between non-invasive SpHb and laboratory reference total haemoglobin (tHb)?
- How accurately can non-invasive SpHb detect clinically significant laboratory anaemia (Hb < 10g/dL)?
- 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.
Read more
Participants will:
- 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.
- 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Spectrophotometry hemoglobin
- Keywords
- neonatal anemia, spectrophotometry hemoglobin, anemia of prematurity, neonatal intensive care unit
- Medical subject headings
- Anemia, Anemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectrophotometry hemoglobinDevice
Also called Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spectrophotometry hemoglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia
- Responsible party
- Principal investigator, Aliyyah Mohammad Khuzaini, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788703
- Sponsor's protocol ID
- 2026219-16355
- Other IDs
- ID RSCH ID-26-05390-RJH
- Acronym
- NeoSpHb
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Publications
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.
PubMed 39806708Nicholas 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.
PubMed 25742288Arai 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.
PubMed 35906313Hsu 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.
PubMed 26702617Causey 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.
PubMed 21545905Noiri 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.
PubMed 16352948
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07788703
- Acronym / sponsor ID
- NeoSpHb / 2026219-16355
- Conditions
- Anemia
- Keywords
- neonatal anemia, spectrophotometry hemoglobin, anemia of prematurity, neonatal intensive care unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the agreement between non-invasive SpHb and laboratory reference total haemoglobin (tHb)?
- How accurately can non-invasive SpHb detect clinically significant laboratory anaemia (Hb < 10g/dL)?
- 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:
- 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.
- 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpHb | Experimental | Device: Spectrophotometry hemoglobinInfants admitted to the NICU will undergo non-invasive SpHb measurement, with results compared against laboratory haemoglobin values obtained as part of routine clinical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectrophotometry hemoglobinAlso: Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology1. 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. | Device | SpHb |
Primary outcome
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
6 secondary outcomes
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
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
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 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 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 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 39806708Saengnipanthkul 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.
- Background: PubMed 25742288Nicholas 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.
- Background: PubMed 35906313Arai 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.
- Background: PubMed 26702617Hsu 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.
- Background: PubMed 21545905Causey 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.
- Background: PubMed 16352948Noiri 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectrophotometry hemoglobin in people with Anemia, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd (+60132134616, aliyyahkhuzaini@usim.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788703, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.