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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Agreement between non-invasive SpHb and laboratory haemoglobin measurements
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Agreement between non-invasive SpHb and laboratory haemoglobin measurements
时间窗: 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
次要结局
- 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).)
- 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).)
研究者
Aliyyah Mohammad Khuzaini
Clinical Fellow in Neonatology
University of Malaya