Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses

In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Developmental neuroscience 2006-01, Vol.28 (4-5), p.276-290
Hauptverfasser: Natale, JoAnne E., Joseph, Jill G., Pretzlaff, Robert K., Silber, Tomas J., Guerguerian, Anne-Marie
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 290
container_issue 4-5
container_start_page 276
container_title Developmental neuroscience
container_volume 28
creator Natale, JoAnne E.
Joseph, Jill G.
Pretzlaff, Robert K.
Silber, Tomas J.
Guerguerian, Anne-Marie
description In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.
doi_str_mv 10.1159/000094154
format Article
fullrecord <record><control><sourceid>proquest_karge</sourceid><recordid>TN_cdi_proquest_journals_221224124</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>68803266</sourcerecordid><originalsourceid>FETCH-LOGICAL-c392t-8c73db29864b736b848352394ca237e0d117e7edc505b56a45b29c88108e3eb23</originalsourceid><addsrcrecordid>eNqN0c9rFDEUB_D4C7utHjwLMngQPIzm5eWnN138UShYpL06ZDKvNetsZk1mDv3vTdmlghfNJSHvky8vPMaeAX8DoNxbXpeToOQ9dowIlgNaJe-zFUgBrbPKPagFy5WyoBU-ZCuOxrbKan3EjkvZcA7CoXnMjkA7iVrBin1fjzHF4MfmIkc_liam5pyG6OccQ73zy9bP9fQh-1o5TZsl37xrLlP8tVCz_uHHkdI1lcanoTmfZkpzTWm-UdlNqVB5wh5d1VR6ethP2OWnjxfrL-3Z18-n6_dnbUAn5tYGg0MvnNWyN6h7Ky0qgU4GL9AQHwAMGRqC4qpX2ktVcbAWuCWkXuAJe7XP3eWpdlbmbhtLoHH0iaaldNpajkLrf0LBHRdG4X9AFNyo28SXf8HNtORUf9sJAUJIELKi13sU8lRKpqtul-PW55sOeHc73e5uutW-OAQu_ZaGP_IwtAqe78FPn68p34H9898wpqEq</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>221224124</pqid></control><display><type>article</type><title>Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses</title><source>MEDLINE</source><source>Karger Journals</source><creator>Natale, JoAnne E. ; Joseph, Jill G. ; Pretzlaff, Robert K. ; Silber, Tomas J. ; Guerguerian, Anne-Marie</creator><creatorcontrib>Natale, JoAnne E. ; Joseph, Jill G. ; Pretzlaff, Robert K. ; Silber, Tomas J. ; Guerguerian, Anne-Marie</creatorcontrib><description>In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.</description><identifier>ISSN: 0378-5866</identifier><identifier>ISBN: 3805581653</identifier><identifier>ISBN: 9783805581653</identifier><identifier>EISSN: 1421-9859</identifier><identifier>EISBN: 3318013854</identifier><identifier>EISBN: 9783318013856</identifier><identifier>DOI: 10.1159/000094154</identifier><identifier>PMID: 16943651</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Brain Injuries - psychology ; Brain Injuries - therapy ; Caregivers - psychology ; Caregivers - statistics &amp; numerical data ; Caregivers - trends ; Child ; Clinical Protocols - standards ; Clinical Research ; Clinical Trials as Topic - ethics ; Clinical Trials as Topic - standards ; Clinical Trials as Topic - trends ; Family - psychology ; Humans ; Informed Consent - psychology ; Informed Consent - standards ; Outcome Assessment (Health Care) - standards ; Outcome Assessment (Health Care) - trends ; Patient Selection - ethics ; Pediatrics - ethics ; Pediatrics - standards ; Pediatrics - trends ; Practice Guidelines as Topic - standards ; Research Support as Topic - statistics &amp; numerical data ; Research Support as Topic - trends</subject><ispartof>Developmental neuroscience, 2006-01, Vol.28 (4-5), p.276-290</ispartof><rights>2006 S. Karger AG, Basel</rights><rights>Copyright (c) 2006 S. Karger AG, Basel.</rights><rights>Copyright (c) 2006 S. Karger AG, Basel</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c392t-8c73db29864b736b848352394ca237e0d117e7edc505b56a45b29c88108e3eb23</citedby><cites>FETCH-LOGICAL-c392t-8c73db29864b736b848352394ca237e0d117e7edc505b56a45b29c88108e3eb23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,2427,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16943651$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Natale, JoAnne E.</creatorcontrib><creatorcontrib>Joseph, Jill G.</creatorcontrib><creatorcontrib>Pretzlaff, Robert K.</creatorcontrib><creatorcontrib>Silber, Tomas J.</creatorcontrib><creatorcontrib>Guerguerian, Anne-Marie</creatorcontrib><title>Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses</title><title>Developmental neuroscience</title><addtitle>Dev Neurosci</addtitle><description>In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.</description><subject>Brain Injuries - psychology</subject><subject>Brain Injuries - therapy</subject><subject>Caregivers - psychology</subject><subject>Caregivers - statistics &amp; numerical data</subject><subject>Caregivers - trends</subject><subject>Child</subject><subject>Clinical Protocols - standards</subject><subject>Clinical Research</subject><subject>Clinical Trials as Topic - ethics</subject><subject>Clinical Trials as Topic - standards</subject><subject>Clinical Trials as Topic - trends</subject><subject>Family - psychology</subject><subject>Humans</subject><subject>Informed Consent - psychology</subject><subject>Informed Consent - standards</subject><subject>Outcome Assessment (Health Care) - standards</subject><subject>Outcome Assessment (Health Care) - trends</subject><subject>Patient Selection - ethics</subject><subject>Pediatrics - ethics</subject><subject>Pediatrics - standards</subject><subject>Pediatrics - trends</subject><subject>Practice Guidelines as Topic - standards</subject><subject>Research Support as Topic - statistics &amp; numerical data</subject><subject>Research Support as Topic - trends</subject><issn>0378-5866</issn><issn>1421-9859</issn><isbn>3805581653</isbn><isbn>9783805581653</isbn><isbn>3318013854</isbn><isbn>9783318013856</isbn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqN0c9rFDEUB_D4C7utHjwLMngQPIzm5eWnN138UShYpL06ZDKvNetsZk1mDv3vTdmlghfNJSHvky8vPMaeAX8DoNxbXpeToOQ9dowIlgNaJe-zFUgBrbPKPagFy5WyoBU-ZCuOxrbKan3EjkvZcA7CoXnMjkA7iVrBin1fjzHF4MfmIkc_liam5pyG6OccQ73zy9bP9fQh-1o5TZsl37xrLlP8tVCz_uHHkdI1lcanoTmfZkpzTWm-UdlNqVB5wh5d1VR6ethP2OWnjxfrL-3Z18-n6_dnbUAn5tYGg0MvnNWyN6h7Ky0qgU4GL9AQHwAMGRqC4qpX2ktVcbAWuCWkXuAJe7XP3eWpdlbmbhtLoHH0iaaldNpajkLrf0LBHRdG4X9AFNyo28SXf8HNtORUf9sJAUJIELKi13sU8lRKpqtul-PW55sOeHc73e5uutW-OAQu_ZaGP_IwtAqe78FPn68p34H9898wpqEq</recordid><startdate>20060101</startdate><enddate>20060101</enddate><creator>Natale, JoAnne E.</creator><creator>Joseph, Jill G.</creator><creator>Pretzlaff, Robert K.</creator><creator>Silber, Tomas J.</creator><creator>Guerguerian, Anne-Marie</creator><general>S. Karger AG</general><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>7QR</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20060101</creationdate><title>Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses</title><author>Natale, JoAnne E. ; Joseph, Jill G. ; Pretzlaff, Robert K. ; Silber, Tomas J. ; Guerguerian, Anne-Marie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c392t-8c73db29864b736b848352394ca237e0d117e7edc505b56a45b29c88108e3eb23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Brain Injuries - psychology</topic><topic>Brain Injuries - therapy</topic><topic>Caregivers - psychology</topic><topic>Caregivers - statistics &amp; numerical data</topic><topic>Caregivers - trends</topic><topic>Child</topic><topic>Clinical Protocols - standards</topic><topic>Clinical Research</topic><topic>Clinical Trials as Topic - ethics</topic><topic>Clinical Trials as Topic - standards</topic><topic>Clinical Trials as Topic - trends</topic><topic>Family - psychology</topic><topic>Humans</topic><topic>Informed Consent - psychology</topic><topic>Informed Consent - standards</topic><topic>Outcome Assessment (Health Care) - standards</topic><topic>Outcome Assessment (Health Care) - trends</topic><topic>Patient Selection - ethics</topic><topic>Pediatrics - ethics</topic><topic>Pediatrics - standards</topic><topic>Pediatrics - trends</topic><topic>Practice Guidelines as Topic - standards</topic><topic>Research Support as Topic - statistics &amp; numerical data</topic><topic>Research Support as Topic - trends</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Natale, JoAnne E.</creatorcontrib><creatorcontrib>Joseph, Jill G.</creatorcontrib><creatorcontrib>Pretzlaff, Robert K.</creatorcontrib><creatorcontrib>Silber, Tomas J.</creatorcontrib><creatorcontrib>Guerguerian, Anne-Marie</creatorcontrib><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>Chemoreception Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</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>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Biotechnology and BioEngineering Abstracts</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>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Developmental neuroscience</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Natale, JoAnne E.</au><au>Joseph, Jill G.</au><au>Pretzlaff, Robert K.</au><au>Silber, Tomas J.</au><au>Guerguerian, Anne-Marie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses</atitle><jtitle>Developmental neuroscience</jtitle><addtitle>Dev Neurosci</addtitle><date>2006-01-01</date><risdate>2006</risdate><volume>28</volume><issue>4-5</issue><spage>276</spage><epage>290</epage><pages>276-290</pages><issn>0378-5866</issn><eissn>1421-9859</eissn><isbn>3805581653</isbn><isbn>9783805581653</isbn><eisbn>3318013854</eisbn><eisbn>9783318013856</eisbn><abstract>In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.</abstract><cop>Basel, Switzerland</cop><pub>S. Karger AG</pub><pmid>16943651</pmid><doi>10.1159/000094154</doi><tpages>15</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0378-5866
ispartof Developmental neuroscience, 2006-01, Vol.28 (4-5), p.276-290
issn 0378-5866
1421-9859
language eng
recordid cdi_proquest_journals_221224124
source MEDLINE; Karger Journals
subjects Brain Injuries - psychology
Brain Injuries - therapy
Caregivers - psychology
Caregivers - statistics & numerical data
Caregivers - trends
Child
Clinical Protocols - standards
Clinical Research
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
Clinical Trials as Topic - trends
Family - psychology
Humans
Informed Consent - psychology
Informed Consent - standards
Outcome Assessment (Health Care) - standards
Outcome Assessment (Health Care) - trends
Patient Selection - ethics
Pediatrics - ethics
Pediatrics - standards
Pediatrics - trends
Practice Guidelines as Topic - standards
Research Support as Topic - statistics & numerical data
Research Support as Topic - trends
title Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-12T03%3A38%3A34IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_karge&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Clinical%20Trials%20in%20Pediatric%20Traumatic%20Brain%20Injury:%20Unique%20Challenges%20and%20Potential%20Responses&rft.jtitle=Developmental%20neuroscience&rft.au=Natale,%20JoAnne%20E.&rft.date=2006-01-01&rft.volume=28&rft.issue=4-5&rft.spage=276&rft.epage=290&rft.pages=276-290&rft.issn=0378-5866&rft.eissn=1421-9859&rft.isbn=3805581653&rft.isbn_list=9783805581653&rft_id=info:doi/10.1159/000094154&rft_dat=%3Cproquest_karge%3E68803266%3C/proquest_karge%3E%3Curl%3E%3C/url%3E&rft.eisbn=3318013854&rft.eisbn_list=9783318013856&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=221224124&rft_id=info:pmid/16943651&rfr_iscdi=true