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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
- Telefonnummer: +60132134616
- E-Mail: aliyyahkhuzaini@usim.edu.my
Studieren Sie die Kontaktsicherung
- Name: Azanna Ahmad Kamar, MBBS, MRCPCH
- Telefonnummer: +603-79492065
- E-Mail: azanna@um.edu.my
Studienorte
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
- University Malaya Medical Center
-
Kontakt:
- Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
- Telefonnummer: +60132134616
- E-Mail: aliyyahkhuzaini@usim.edu.my
-
Kontakt:
- Minn Yin Choo, MBBS, MMed, MRCPCH
- Telefonnummer: +603-79492065
- E-Mail: minnyin@ummc.edu.my
-
Hauptermittler:
- Aliyyah Mohammad Khuzaini, MBChB, MRCPCH, MMEd
-
Unterermittler:
- Minn Yin Choo, MBBS, MMed, MRCPCH
-
Unterermittler:
- Azanna Ahmad Kamar, MBBS, MRCPCH
-
Unterermittler:
- Tengku Amatullah Madeehah Tengku Mohd, MBChB, MSc, MPH, DrPH
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Agreement between non-invasive SpHb and laboratory haemoglobin measurements
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sensitivity and specificity of SpHb for detection of anaemia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026219-16355
- ID RSCH ID-26-05390-RJH (Registrierungskennung: National Medical Research Registry, Malaysia)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .