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

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.

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.

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.