NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU) (NeoSpHb)
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.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
- 전화번호: +60132134616
- 이메일: aliyyahkhuzaini@usim.edu.my
연구 연락처 백업
- 이름: Azanna Ahmad Kamar, MBBS, MRCPCH
- 전화번호: +603-79492065
- 이메일: azanna@um.edu.my
연구 장소
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, 말레이시아, 50603
- University Malaya Medical Center
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연락하다:
- Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
- 전화번호: +60132134616
- 이메일: aliyyahkhuzaini@usim.edu.my
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연락하다:
- Minn Yin Choo, MBBS, MMed, MRCPCH
- 전화번호: +603-79492065
- 이메일: minnyin@ummc.edu.my
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수석 연구원:
- Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
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부수사관:
- Minn Yin Choo, MBBS, MMed, MRCPCH
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부수사관:
- Azanna Ahmad Kamar, MBBS, MRCPCH
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부수사관:
- Tengku Amatullah Madeehah Tengku Mohd, MBChB, MSc, MPH, DrPH
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SpHb
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.
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Agreement between non-invasive SpHb and laboratory haemoglobin measurements
기간: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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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 |
During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity and specificity of SpHb for detection of anaemia
기간: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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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 |
During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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Agreement between changes in SpHb and changes in laboratory haemoglobin over time
기간: During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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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 |
During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
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Regression coefficient for perfusion index and SpHb-tHb measurement difference
기간: From enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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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 |
From enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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Regression coefficient for gestational age and SpHb-tHb measurement difference
기간: Gestational age recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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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 |
Gestational age recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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Regression coefficient for birth weight and SpHb-tHb measurement difference
기간: Birth weight recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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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 |
Birth weight recorded at birth; association assessed from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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Regression coefficient for phototherapy and SpHb-tHb measurement difference
기간: Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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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) |
Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Causey 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.
- Nicholas 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.
- 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.
- Arai 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.
- Hsu 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.
- Noiri 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026219-16355
- ID RSCH ID-26-05390-RJH (레지스트리 식별자: National Medical Research Registry, Malaysia)
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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