Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device
IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), base...
Gespeichert in:
| Veröffentlicht in: | BMJ open 2019-03, Vol.9 (3), p.e027442-e027442 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e027442 |
|---|---|
| container_issue | 3 |
| container_start_page | e027442 |
| container_title | BMJ open |
| container_volume | 9 |
| creator | Reis, Zilma Silveira Nogueira Guimarães, Rodney Nascimento Rego, Maria Albertina Santiago Maia de Castro Romanelli, Roberta Gaspar, Juliano de Souza Vitral, Gabriela Luiza Nogueira dos Reis, Marconi Augusto Aguiar Colósimo, Enrico Antônio Neves, Gabriela Silveira Vale, Marynea Silva Nader, Paulo de Jesus Hartamann de Moura, Marta David Rocha de Aguiar, Regina Amélia Pessoa Lopes |
| description | IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysisResearch protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.Ethics and disseminationEach local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.Trial registration numberRBR-3f5bm5. |
| doi_str_mv | 10.1136/bmjopen-2018-027442 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6429838</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2188982727</sourcerecordid><originalsourceid>FETCH-LOGICAL-b472t-da01ede9d1fcb0e64dba8a3e61971f4ba3639443e732e469d899f0c98d046aff3</originalsourceid><addsrcrecordid>eNqNks1u1DAUhSMEolXpEyAhS2zYpPgvic0CCSpokSrBAtaWE9_MeHDs4DhTlSfksfAkQ1VY4YVt2d85vtc6RfGc4AtCWP26HXZhBF9STESJacM5fVScUsx5WeOqevxgf1KcT9MO58ErWVX0aXHCsOCUEHla_PoSYdBpjjbdIQMJumSDR7DXbtbJ-g2yPkHU63EL6RbAo7QFNH23HoV-2Xu4bUP0SHuDnN1s0xs0xpBCFxzqQ1yYMQIMFsoEU0LD7JLtwKcIqHPW2047lKLNc3Z9H_VP66z2aBum0SbtJpQCyjVZoxMgfXgQDWAWmYF9tnpWPOkzB-fH9az49vHD18vr8ubz1afLdzdlyxuaSqMxAQPSkL5rMdTctFpoBjWRDel5q1nNJOcMGkaB19IIKXvcSWEwr3Xfs7Pi7eo7zm2uYOlBOzVGO-h4p4K26u8bb7dqE_aq5lQKJrLBq6NBDD_m_BlqsFMHzmkPYZ4UJUJIQRvaZPTlP-guzNHn9hYKS97UdabYSnUxTFOE_r4YgtUhLOoYFnUIi1rDklUvHvZxr_kTjQxcrEBW_5fjb1Nz0fg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2188094766</pqid></control><display><type>article</type><title>Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device</title><source>BMJ Open Access Journals</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Reis, Zilma Silveira Nogueira ; Guimarães, Rodney Nascimento ; Rego, Maria Albertina Santiago ; Maia de Castro Romanelli, Roberta ; Gaspar, Juliano de Souza ; Vitral, Gabriela Luiza Nogueira ; dos Reis, Marconi Augusto Aguiar ; Colósimo, Enrico Antônio ; Neves, Gabriela Silveira ; Vale, Marynea Silva ; Nader, Paulo de Jesus Hartamann ; de Moura, Marta David Rocha ; de Aguiar, Regina Amélia Pessoa Lopes</creator><creatorcontrib>Reis, Zilma Silveira Nogueira ; Guimarães, Rodney Nascimento ; Rego, Maria Albertina Santiago ; Maia de Castro Romanelli, Roberta ; Gaspar, Juliano de Souza ; Vitral, Gabriela Luiza Nogueira ; dos Reis, Marconi Augusto Aguiar ; Colósimo, Enrico Antônio ; Neves, Gabriela Silveira ; Vale, Marynea Silva ; Nader, Paulo de Jesus Hartamann ; de Moura, Marta David Rocha ; de Aguiar, Regina Amélia Pessoa Lopes</creatorcontrib><description>IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysisResearch protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.Ethics and disseminationEach local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.Trial registration numberRBR-3f5bm5.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-027442</identifier><identifier>PMID: 30842119</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Accuracy ; Brazil - epidemiology ; Case-Control Studies ; Childbirth & labor ; Clinical trials ; Feasibility studies ; Female ; Gestational Age ; Hospitals ; Humans ; Infant, Newborn ; Infant, Premature - physiology ; Innovations ; Medical technology ; Neonatal care ; Neonatal Screening ; Newborn babies ; Obstetrics and Gynaecology ; Optics and Photonics - instrumentation ; Optics and Photonics - methods ; Patient assessment ; Pediatrics ; Pregnancy ; Reference Standards ; Respiratory distress syndrome ; Skin - physiopathology ; Skin Physiological Phenomena ; Ultrasonic imaging ; Usability</subject><ispartof>BMJ open, 2019-03, Vol.9 (3), p.e027442-e027442</ispartof><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.</rights><rights>2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-da01ede9d1fcb0e64dba8a3e61971f4ba3639443e732e469d899f0c98d046aff3</citedby><cites>FETCH-LOGICAL-b472t-da01ede9d1fcb0e64dba8a3e61971f4ba3639443e732e469d899f0c98d046aff3</cites><orcidid>0000-0001-6374-9295</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/9/3/e027442.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/9/3/e027442.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77344,77375</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30842119$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Reis, Zilma Silveira Nogueira</creatorcontrib><creatorcontrib>Guimarães, Rodney Nascimento</creatorcontrib><creatorcontrib>Rego, Maria Albertina Santiago</creatorcontrib><creatorcontrib>Maia de Castro Romanelli, Roberta</creatorcontrib><creatorcontrib>Gaspar, Juliano de Souza</creatorcontrib><creatorcontrib>Vitral, Gabriela Luiza Nogueira</creatorcontrib><creatorcontrib>dos Reis, Marconi Augusto Aguiar</creatorcontrib><creatorcontrib>Colósimo, Enrico Antônio</creatorcontrib><creatorcontrib>Neves, Gabriela Silveira</creatorcontrib><creatorcontrib>Vale, Marynea Silva</creatorcontrib><creatorcontrib>Nader, Paulo de Jesus Hartamann</creatorcontrib><creatorcontrib>de Moura, Marta David Rocha</creatorcontrib><creatorcontrib>de Aguiar, Regina Amélia Pessoa Lopes</creatorcontrib><title>Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysisResearch protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.Ethics and disseminationEach local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.Trial registration numberRBR-3f5bm5.</description><subject>Accuracy</subject><subject>Brazil - epidemiology</subject><subject>Case-Control Studies</subject><subject>Childbirth & labor</subject><subject>Clinical trials</subject><subject>Feasibility studies</subject><subject>Female</subject><subject>Gestational Age</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Premature - physiology</subject><subject>Innovations</subject><subject>Medical technology</subject><subject>Neonatal care</subject><subject>Neonatal Screening</subject><subject>Newborn babies</subject><subject>Obstetrics and Gynaecology</subject><subject>Optics and Photonics - instrumentation</subject><subject>Optics and Photonics - methods</subject><subject>Patient assessment</subject><subject>Pediatrics</subject><subject>Pregnancy</subject><subject>Reference Standards</subject><subject>Respiratory distress syndrome</subject><subject>Skin - physiopathology</subject><subject>Skin Physiological Phenomena</subject><subject>Ultrasonic imaging</subject><subject>Usability</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNks1u1DAUhSMEolXpEyAhS2zYpPgvic0CCSpokSrBAtaWE9_MeHDs4DhTlSfksfAkQ1VY4YVt2d85vtc6RfGc4AtCWP26HXZhBF9STESJacM5fVScUsx5WeOqevxgf1KcT9MO58ErWVX0aXHCsOCUEHla_PoSYdBpjjbdIQMJumSDR7DXbtbJ-g2yPkHU63EL6RbAo7QFNH23HoV-2Xu4bUP0SHuDnN1s0xs0xpBCFxzqQ1yYMQIMFsoEU0LD7JLtwKcIqHPW2047lKLNc3Z9H_VP66z2aBum0SbtJpQCyjVZoxMgfXgQDWAWmYF9tnpWPOkzB-fH9az49vHD18vr8ubz1afLdzdlyxuaSqMxAQPSkL5rMdTctFpoBjWRDel5q1nNJOcMGkaB19IIKXvcSWEwr3Xfs7Pi7eo7zm2uYOlBOzVGO-h4p4K26u8bb7dqE_aq5lQKJrLBq6NBDD_m_BlqsFMHzmkPYZ4UJUJIQRvaZPTlP-guzNHn9hYKS97UdabYSnUxTFOE_r4YgtUhLOoYFnUIi1rDklUvHvZxr_kTjQxcrEBW_5fjb1Nz0fg</recordid><startdate>20190305</startdate><enddate>20190305</enddate><creator>Reis, Zilma Silveira Nogueira</creator><creator>Guimarães, Rodney Nascimento</creator><creator>Rego, Maria Albertina Santiago</creator><creator>Maia de Castro Romanelli, Roberta</creator><creator>Gaspar, Juliano de Souza</creator><creator>Vitral, Gabriela Luiza Nogueira</creator><creator>dos Reis, Marconi Augusto Aguiar</creator><creator>Colósimo, Enrico Antônio</creator><creator>Neves, Gabriela Silveira</creator><creator>Vale, Marynea Silva</creator><creator>Nader, Paulo de Jesus Hartamann</creator><creator>de Moura, Marta David Rocha</creator><creator>de Aguiar, Regina Amélia Pessoa Lopes</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6374-9295</orcidid></search><sort><creationdate>20190305</creationdate><title>Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device</title><author>Reis, Zilma Silveira Nogueira ; Guimarães, Rodney Nascimento ; Rego, Maria Albertina Santiago ; Maia de Castro Romanelli, Roberta ; Gaspar, Juliano de Souza ; Vitral, Gabriela Luiza Nogueira ; dos Reis, Marconi Augusto Aguiar ; Colósimo, Enrico Antônio ; Neves, Gabriela Silveira ; Vale, Marynea Silva ; Nader, Paulo de Jesus Hartamann ; de Moura, Marta David Rocha ; de Aguiar, Regina Amélia Pessoa Lopes</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-da01ede9d1fcb0e64dba8a3e61971f4ba3639443e732e469d899f0c98d046aff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Accuracy</topic><topic>Brazil - epidemiology</topic><topic>Case-Control Studies</topic><topic>Childbirth & labor</topic><topic>Clinical trials</topic><topic>Feasibility studies</topic><topic>Female</topic><topic>Gestational Age</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Premature - physiology</topic><topic>Innovations</topic><topic>Medical technology</topic><topic>Neonatal care</topic><topic>Neonatal Screening</topic><topic>Newborn babies</topic><topic>Obstetrics and Gynaecology</topic><topic>Optics and Photonics - instrumentation</topic><topic>Optics and Photonics - methods</topic><topic>Patient assessment</topic><topic>Pediatrics</topic><topic>Pregnancy</topic><topic>Reference Standards</topic><topic>Respiratory distress syndrome</topic><topic>Skin - physiopathology</topic><topic>Skin Physiological Phenomena</topic><topic>Ultrasonic imaging</topic><topic>Usability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reis, Zilma Silveira Nogueira</creatorcontrib><creatorcontrib>Guimarães, Rodney Nascimento</creatorcontrib><creatorcontrib>Rego, Maria Albertina Santiago</creatorcontrib><creatorcontrib>Maia de Castro Romanelli, Roberta</creatorcontrib><creatorcontrib>Gaspar, Juliano de Souza</creatorcontrib><creatorcontrib>Vitral, Gabriela Luiza Nogueira</creatorcontrib><creatorcontrib>dos Reis, Marconi Augusto Aguiar</creatorcontrib><creatorcontrib>Colósimo, Enrico Antônio</creatorcontrib><creatorcontrib>Neves, Gabriela Silveira</creatorcontrib><creatorcontrib>Vale, Marynea Silva</creatorcontrib><creatorcontrib>Nader, Paulo de Jesus Hartamann</creatorcontrib><creatorcontrib>de Moura, Marta David Rocha</creatorcontrib><creatorcontrib>de Aguiar, Regina Amélia Pessoa Lopes</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reis, Zilma Silveira Nogueira</au><au>Guimarães, Rodney Nascimento</au><au>Rego, Maria Albertina Santiago</au><au>Maia de Castro Romanelli, Roberta</au><au>Gaspar, Juliano de Souza</au><au>Vitral, Gabriela Luiza Nogueira</au><au>dos Reis, Marconi Augusto Aguiar</au><au>Colósimo, Enrico Antônio</au><au>Neves, Gabriela Silveira</au><au>Vale, Marynea Silva</au><au>Nader, Paulo de Jesus Hartamann</au><au>de Moura, Marta David Rocha</au><au>de Aguiar, Regina Amélia Pessoa Lopes</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2019-03-05</date><risdate>2019</risdate><volume>9</volume><issue>3</issue><spage>e027442</spage><epage>e027442</epage><pages>e027442-e027442</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysisResearch protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.Ethics and disseminationEach local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.Trial registration numberRBR-3f5bm5.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30842119</pmid><doi>10.1136/bmjopen-2018-027442</doi><orcidid>https://orcid.org/0000-0001-6374-9295</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2019-03, Vol.9 (3), p.e027442-e027442 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6429838 |
| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; PubMed Central Open Access |
| subjects | Accuracy Brazil - epidemiology Case-Control Studies Childbirth & labor Clinical trials Feasibility studies Female Gestational Age Hospitals Humans Infant, Newborn Infant, Premature - physiology Innovations Medical technology Neonatal care Neonatal Screening Newborn babies Obstetrics and Gynaecology Optics and Photonics - instrumentation Optics and Photonics - methods Patient assessment Pediatrics Pregnancy Reference Standards Respiratory distress syndrome Skin - physiopathology Skin Physiological Phenomena Ultrasonic imaging Usability |
| title | Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-28T23%3A05%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Prematurity%20detection%20evaluating%20interaction%20between%20the%20skin%20of%20the%20newborn%20and%20light:%20protocol%20for%20the%20preemie-test%20multicentre%20clinical%20trial%20in%20Brazilian%20hospitals%20to%20validate%20a%20new%20medical%20device&rft.jtitle=BMJ%20open&rft.au=Reis,%20Zilma%20Silveira%20Nogueira&rft.date=2019-03-05&rft.volume=9&rft.issue=3&rft.spage=e027442&rft.epage=e027442&rft.pages=e027442-e027442&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2018-027442&rft_dat=%3Cproquest_pubme%3E2188982727%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2188094766&rft_id=info:pmid/30842119&rfr_iscdi=true |