An interventional study of Spectrophotometry hemoglobin in Anemia, sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Malaya · Not applicable, Interventional, and Diagnostic
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:
Participants will:
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 30 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Time frame: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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
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
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
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
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
Time frame: 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
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
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
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
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)
Time frame: Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Plan to share: 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
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 163 non-industry interventional studies with no phase under Anemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's planned 6 months is below that.
Counting every sponsor, half of 177 studies reached it within 17 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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