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

24 août 2026 mis à jour par: Aliyyah Mohammad Khuzaini, University of Malaya

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Azanna Ahmad Kamar, MBBS, MRCPCH
  • Numéro de téléphone: +603-79492065
  • E-mail: azanna@um.edu.my

Lieux d'étude

  • Malaisie
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaisie, 50603
        • University Malaya Medical Center
        • Contact:
        • Contact:
          • Minn Yin Choo, MBBS, MMed, MRCPCH
          • Numéro de téléphone: +603-79492065
          • E-mail: minnyin@ummc.edu.my
        • Chercheur principal:
          • Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
        • Sous-enquêteur:
          • Minn Yin Choo, MBBS, MMed, MRCPCH
        • Sous-enquêteur:
          • Azanna Ahmad Kamar, MBBS, MRCPCH
        • Sous-enquêteur:
          • Tengku Amatullah Madeehah Tengku Mohd, MBChB, MSc, MPH, DrPH

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • Masimo Radical-7® Pulse CO-Oximeter with rainbow® technology

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Agreement between non-invasive SpHb and laboratory haemoglobin measurements
Délai: 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
During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sensitivity and specificity of SpHb for detection of anaemia
Délai: 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
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
Délai: 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
During NICU hospitalization, from enrolment until hospital discharge, up to 44 weeks postmenstrual age
Regression coefficient for perfusion index and SpHb-tHb measurement difference
Délai: 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
From enrollment through NICU discharge (up to 44 weeks postmenstrual age).
Regression coefficient for gestational age and SpHb-tHb measurement difference
Délai: 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
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
Délai: 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
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
Délai: 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)
Assessed at each paired SpHb-tHb measurement, from enrollment through NICU discharge (up to 44 weeks postmenstrual age).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Malaya

Collaborateurs

Universiti Sains Islam Malaysia

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 mars 2027

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

14 août 2026

Première soumission répondant aux critères de contrôle qualité

24 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026219-16355
  • ID RSCH ID-26-05390-RJH (Identificateur de registre: National Medical Research Registry, Malaysia)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

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