Anemia
Conditions
Keywords
neonatal anemia, spectrophotometry hemoglobin, anemia of prematurity, neonatal intensive care unit
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. 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.
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.
Interventions
DEVICESpectrophotometry 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.
Sponsors
University of Malaya
Universiti Sains Islam Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between non-invasive SpHb and laboratory haemoglobin measurements | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of SpHb for detection of anaemia | 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 |
| 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 | 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 |
| Regression coefficient for perfusion index and SpHb-tHb measurement difference | 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 |
| 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 (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 |
| 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). | 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 |
| Regression coefficient for phototherapy and SpHb-tHb measurement difference | 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) |
Countries
Malaysia
Contacts
CONTACTAliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
CONTACTAzanna Ahmad Kamar, MBBS, MRCPCH
Outcome results
None listed