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Assessment of fetal lung maturity by ultrasound texture analysis
fetal i+D - Fetal Medicine Research CenterBCNatal – Centre de Medicina Maternofetal i Neonatologia de Barcelona
Hospital Clínic - Hospital Sant Joan de Déu Universitat de Barcelona
www.medicinafetalbarcelona.org/
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL
PROTOCOLS DE MEDICINA FETAL I PERINATAL BCNatal | HOSPITAL CLÍNIC- HOSPITAL SANT JOAN DE DÉU- UNIVERSITAT DE BARCELONA
4/4
INDICACIÓN DE FINALIZACIÓN (o información sobre madurez pulmonar fetal)
4/4
≥"35.0"'"<39.0!!sem!Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).!
!"
<"35.0"sem"Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.!
"
A!partir!del!día!siguiente!a!la!!2ª!dosis:!
BAJO!riesgo!de!!morbilidad!respiratoria!neonatal*!
ALTO!riesgo!de!morbilidad!respiratoria!neonatal*
Programar!finalización
Según!indicación!y!EG,!considerar:!N!demorar!!3N7!días!la!finalización!y/o!!N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!!N!reevaluar!quantusFLM®!en!1!sem!o!N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología!!
NO"ha"recibido"corticoides:!!corticoides.!
(1)"Ejemplos"de"situaciones"potenciales":"NHipertensión!crónica!o!diabetes!de!difícil!control.!NBalance!hídrico!positive!con!discomfort!severo!materno.!NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.!NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.!NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.!N!…!
N Si!inducción!del!parto!y!<!37.0!sem!o!!N Si!CS!electiva!y!<!39.0!sem!
Ha"recibido"corticoides"y"quantusFLM®"disponible"
!(si!no!disponible,!administrar!corticoides!de!acuerdo!con!recomendaciones)!!
Programar!finalización
*Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea!transitoria!neonatal
BAJO!riesgo!de!!morbilidad!respiratoria!neonatal*!
9
MPFMPF
(*IF CORTICOIDS REDUCE 40% RISK)
36.0w, 38y, IVFChronic HT + poorly controlled diabetes. Edema with maternal discomfort
No absolute medical indication.
LOW RISK=2%
Delivery.
HIGH RISK=36%
Risk probably higher than waiting.Wait 1w and repeat test
INDIVIDUALIZED: TEST LUNG MATURITY
¿RISK NRM?
BASELINE: AT 36W = 6%
www.medicinafetalbarcelona.org/
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org
Is it possible to use ultrasound to test fetal lung maturity?
Background
Grannum, P.A., R.L. Berkowitz, and J.C. Hobbins, The ultrasonic changes in the maturing placenta and their relation to fetal pulmonic maturity. Am J Obstet Gynecol, 1979.
Fried, A.M., et al., Echogenicity of fetal lung: relation to fetal age and maturity. AJR Am J Roentgenol, 1985
Harman, C.R., et al., The correlation of ultrasonic placental grading and fetal pulmonary maturation in five hundred sixty-three pregnancies. Am J Obstet Gynecol, 1982.
Golde, S.H., M.P. Tahilramaney, and L.D. Platt, Use of ultrasound to predict fetal lung maturity in 247 consecutive elective cesarean deliveries. J Reprod Med, 1984.
Zilianti, M. and S. Fernandez, Correlation of ultrasonic images of fetal intestine with gestational age and fetal maturity. Obstet Gynecol, 1983.
Feingold, M., et al., Fetal lung to liver reflectivity ratio and lung maturity. J Clin Ultrasound, 1987.
TRANSMURAL
BIOTECH
Fetal and Perinatal Medicine Research Group
www.medicinafetalbarcelona.org
Is it possible to use ultrasound to test fetal lung maturity?
Background
Quantitative ultrasound analysis
Chen, D.R., et al., Diagnosis of breast tumors with sonographic texture analysis using wavelet transform and neural networks. Ultrasound Med Biol, 2002.
Wan, C., et al., Evaluation of breast lesions by contrast enhanced ultrasound: Qualitative and quantitative analysis. Eur J Radiol. 2011.
Hartman, P.C., et al., Variability of quantitative echographic parameters of the liver: intra- and interindividual spread, temporal- and age-related effects. Ultrasound Med Biol, 1991.
Kadah, Y.M., et al., Classification algorithms for quantitative tissue characterization of diffuse liver disease from ultrasound images. IEEE Trans Med Imaging, 1996.
Tekesin, I., et al., Assessment of fetal lung development by quantitative ultrasonic tissue characterization: a methodical study. Prenat Diagn, 2004.
Maeda, K.S., M., Fetal lung immaturity assessment with ultrasonic tissue characterization:GLHW. 26th The Fetus as a Patient, San Diego, 16:40, April 27 2010.
TRANSMURAL
BIOTECH
Fetal and Perinatal Medicine Research Group
www.medicinafetalbarcelona.org/
Describe fetal lung texture along gestation
900 pregnant women from 16.0 to 42.0 weeks
Inclusion criteria: Low risk pregnant women
Exclusion criteria: Fetal malformations, Multiple gestation
Design : STEP 1
www.medicinafetalbarcelona.org/
Correlate fetal lung texture with the FLM-TDx II
Design : STEP 2
To perform 2D US image the same day (± 12 h) of AF collection
Graphical User Interface (GUI) delineation
FLM results obtained by amniocentesis: mature/immature
www.medicinafetalbarcelona.org/
Correlate fetal lung texture (AQUA) with the FLM-TDx II
Design : STEP 2
n 69
(range 24.6 to 40.2 w)
Sensitivity of 86%, Specificity of 98%, Accuracy of 90%
• Mature: n= 22
• Immature: n = 47
Performance of an automatic quantitative ultrasound analysis (AQUA) texture extractor to predict fetal lung maturity assessed by TDx-FLM in amniotic fluid.Palacio M, Cobo T, Martínez M, Rattá G, Elías N, Bonet E, Amat I, Gratacós E. Award of Research Excellence. Oral presentation SMFM 2012, Dallas.
www.medicinafetalbarcelona.org/
957 imagesFrom June 2010 to December 2010900 images
Design : STEP 1
R Pearson correlation = 0.98Do not use direct grey levelDo not use tissue referenceVarious settings admittedNot strictly influenced by the ROI acquiredAnalysis off-line
www.medicinafetalbarcelona.org/
• N=144• Singleton pregnancies • 29.0 - 38.6 w • Axial thoracic section
Neonatal Respiratory Morbidity (*):• Respiratory Distress Syndrome• Transient tachypnea of newborn
(*) RDS: Respiratory symptoms (eg, grunGng, flaring, tachypnea, retracGons), O2 requirement + chest Rx + NICU admission TT: chest Rx impression + clinical diagnosis by clinician in charge.JAMA 2010
Patient & Provider Informationwww.quantusFLM.com
Sabino Arana 38 1‐108028 Barcelona, SpainCIF: B‐65084675
PATIENT NAME: CLINIC NAME:
PATIENT ID: REFERRING/ORDERING CLINICIAN:
QUANTUSFLM ID: REPORT DATE: (dd/mm/yyyy)
Name Surname
NHC12345678
btech‐123
Complete Center Name
Clinician Name Surname
01/01/2000
Sample Information
GESTATIONAL AGE:
US ACQUISITION DATE:(dd/mm/yyyy)
REQUEST DATE:(dd/mm/yyyy hh:mm)
## weeks # days
01/01/2000
01/01/2000 00:00
Test Result NEONATAL RESPIRATORY MORBIDITY
QUANTUSFLM ID:
RESULT:
Theoretical risk for ## weeks of gestation:
quantusFLM risk:
RECOMMENDATION:(dd/mm/yyyy)
AUTHORIZED SIGNER/S:
Technical Responsible:Elisenda Bonet i Carné, MSc
Imatge Firma
CLINICAL DATA ‐ SPECIFICATIONSAccuracy 87% (95% CI:82‐90%)
Sensitivity 91% (95% CI:77‐98%)
Specificity 86% (95% CI:82‐90%)
Positive Predictive Value 47% (95% CI:35‐59%)
Negative Predictive Value 98% (95% CI:96‐99%)
TEST DESCRIPTIONquantusFLM™ offers an automatic assessment of neonatal respiratory morbidity risk using an ultrasoundimage of the lateral axial transverse section of the fetal thorax at the level of the 4‐chamber section of thefetal heart. quantusFLM™ is based on quantitative ultrasound texture analysis to extract information fromultrasound images and a classifier which uses the extracted information to assess the risk. Test resultdepends on the delineation of the fetal lung and incorporated the gestational age. Neonatal respiratorymorbidity is defined as respiratory distress syndrome or transient tachypnea of the newborn.Test has been validated in singleton pregnancies from 28.0 to 39.0 weeks of gestation. Test are neitherintended nor validated for use in pregnancies with fetal structural abnormalities, chromosomalabnormalities, multiple pregnancies or maternal BMI>35. This result should not be considered as a finalindication but as additional information to be considered in evaluation of the patient.
quantusFLM Test is intended for clinical use and should not be regarded as investigational or for research. Present result has been obtained using quantusFLM X.X. Under the previous of Law 15/1999 normative, we inform you that your data will be included in a data base owned by TransmuralBiotech, S.L. for its clinical treatment. You may exercise the rights of access, rectification, cancellation and opposition contacting us at [email protected].
REFERENCE: Quantitative ultrasound texture analysis of fetal lung to predict neonatal respiratory morbidity. UOG (2014)
Non‐Invasive Assessment of therisk of Neonatal Respiratory morbidity
Graphic Test Result NEONATAL RESPIRATORY MORBIDITY RISK
HIGH LOWRISK RISK
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
Theoretical Risk*
quantusFLM Risk
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
LOW RISK
##.# %
##.# %
Review results with patient
btech‐123
www.medicinafetalbarcelona.org/
Conclusions
• Quantitative ultrasound fetal lung maturity analysis predicted neonatal respiratory morbidity with an accuracy comparable to current tests using amniotic fluid.
• Results being validated in international multicenter trial (n>700)
COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL
PROTOCOLS DE MEDICINA FETAL I PERINATAL BCNatal | HOSPITAL CLÍNIC- HOSPITAL SANT JOAN DE DÉU- UNIVERSITAT DE BARCELONA
4/4
INDICACIÓN DE FINALIZACIÓN (o información sobre madurez pulmonar fetal)
4/4
≥"35.0"'"<39.0!!sem!Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).!
!"
<"35.0"sem"Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.!
"
A!partir!del!día!siguiente!a!la!!2ª!dosis:!
BAJO!riesgo!de!!morbilidad!respiratoria!neonatal*!
ALTO!riesgo!de!morbilidad!respiratoria!neonatal*
Programar!finalización
Según!indicación!y!EG,!considerar:!N!demorar!!3N7!días!la!finalización!y/o!!N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!!N!reevaluar!quantusFLM®!en!1!sem!o!N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología!!
NO"ha"recibido"corticoides:!!corticoides.!
(1)"Ejemplos"de"situaciones"potenciales":"NHipertensión!crónica!o!diabetes!de!difícil!control.!NBalance!hídrico!positive!con!discomfort!severo!materno.!NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.!NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.!NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.!N!…!
N Si!inducción!del!parto!y!<!37.0!sem!o!!N Si!CS!electiva!y!<!39.0!sem!
Ha"recibido"corticoides"y"quantusFLM®"disponible"
!(si!no!disponible,!administrar!corticoides!de!acuerdo!con!recomendaciones)!!
Programar!finalización
*Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea!transitoria!neonatal
BAJO!riesgo!de!!morbilidad!respiratoria!neonatal*!
22
(*IF CORTICOIDS REDUCE 40% RISK)
36.0w, 38y, IVFChronic HT + poorly controlled diabetes. Edema with maternal discomfort
No absolute medical indication.
LOW RISK=2%
Delivery.
HIGH RISK=36%
Risk probably higher than waiting.Wait 1w and repeat test
INDIVIDUALIZED: TEST LUNG MATURITY
¿RISK NRM?
BASELINE: AT 36W = 6%