<?xml version="1.0" encoding="utf-8"?>
<TEI xmlns="http://www.tei-c.org/ns/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:hal="http://hal.archives-ouvertes.fr/" xmlns:gml="http://www.opengis.net/gml/3.3/" xmlns:gmlce="http://www.opengis.net/gml/3.3/ce" version="1.1" xsi:schemaLocation="http://www.tei-c.org/ns/1.0 http://api.archives-ouvertes.fr/documents/aofr-sword.xsd">
  <teiHeader>
    <fileDesc>
      <titleStmt>
        <title>HAL TEI export of hal-04606190</title>
      </titleStmt>
      <publicationStmt>
        <distributor>CCSD</distributor>
        <availability status="restricted">
          <licence target="https://creativecommons.org/publicdomain/zero/1.0/">CC0 1.0 - Universal</licence>
        </availability>
        <date when="2026-05-09T13:23:32+02:00"/>
      </publicationStmt>
      <sourceDesc>
        <p part="N">HAL API Platform</p>
      </sourceDesc>
    </fileDesc>
  </teiHeader>
  <text>
    <body>
      <listBibl>
        <biblFull>
          <titleStmt>
            <title xml:lang="en">Strengthening Reporting of Neonatal Trials</title>
            <author role="aut">
              <persName>
                <forename type="first">James</forename>
                <surname>Webbe</surname>
              </persName>
              <idno type="halauthorid">3169856-0</idno>
              <affiliation ref="#struct-1200422"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Ami</forename>
                <surname>Baba</surname>
              </persName>
              <idno type="halauthorid">3169857-0</idno>
              <affiliation ref="#struct-167754"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Nancy</forename>
                <surname>Butcher</surname>
              </persName>
              <idno type="halauthorid">2200846-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Craig</forename>
                <surname>Rodrigues</surname>
              </persName>
              <idno type="halauthorid">3169858-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Emma</forename>
                <surname>Stallwood</surname>
              </persName>
              <idno type="halauthorid">3169859-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Katherine</forename>
                <surname>Goren</surname>
              </persName>
              <idno type="halauthorid">3169860-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Andrea</forename>
                <surname>Monsour</surname>
              </persName>
              <idno type="halauthorid">3169861-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Alvin</forename>
                <surname>Chang</surname>
              </persName>
              <idno type="halauthorid">3169862-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Amit</forename>
                <surname>Trivedi</surname>
              </persName>
              <idno type="halauthorid">3169863-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Brett</forename>
                <surname>Manley</surname>
              </persName>
              <idno type="halauthorid">3169864-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Emma</forename>
                <surname>Mccall</surname>
              </persName>
              <idno type="halauthorid">3169865-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Fiona</forename>
                <surname>Bogossian</surname>
              </persName>
              <idno type="halauthorid">3169866-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Fumihiko</forename>
                <surname>Namba</surname>
              </persName>
              <idno type="halauthorid">3169867-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Georg</forename>
                <surname>Schmölzer</surname>
              </persName>
              <idno type="halauthorid">3111804-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Himanshu</forename>
                <surname>Popat</surname>
              </persName>
              <idno type="halauthorid">3097928-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Kim An</forename>
                <surname>Nguyen</surname>
              </persName>
              <email type="md5">79e9319abd65af88dbbcde042f02a016</email>
              <email type="domain">chu-lyon.fr</email>
              <idno type="idhal" notation="string">nguyenan</idno>
              <idno type="idhal" notation="numeric">1390361</idno>
              <idno type="halauthorid" notation="string">1317202-1390361</idno>
              <idno type="RESEARCHERID">http://www.researcherid.com/rid/AGT-1300-2022</idno>
              <idno type="RESEARCHERID">http://www.researcherid.com/rid/http://www.researcherid.com/rid/AGT-1300-2022</idno>
              <affiliation ref="#struct-10025"/>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Lex</forename>
                <surname>Doyle</surname>
              </persName>
              <idno type="halauthorid">1777340-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Luke</forename>
                <surname>Jardine</surname>
              </persName>
              <idno type="halauthorid">3169868-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Matthew</forename>
                <surname>Rysavy</surname>
              </persName>
              <idno type="halauthorid">3169869-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Menelaos</forename>
                <surname>Konstantinidis</surname>
              </persName>
              <idno type="halauthorid">3169870-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Muhd Alwi</forename>
                <surname>Muhd Helmi</surname>
              </persName>
              <idno type="halauthorid">3169871-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Nai Ming</forename>
                <surname>Lai</surname>
              </persName>
              <idno type="halauthorid">3169872-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Susanne</forename>
                <surname>Hay</surname>
              </persName>
              <idno type="halauthorid">3169873-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Wes</forename>
                <surname>Onland</surname>
              </persName>
              <idno type="halauthorid">3117977-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Yao Mun</forename>
                <surname>Choo</surname>
              </persName>
              <idno type="halauthorid">3169874-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Chris</forename>
                <surname>Gale</surname>
              </persName>
              <idno type="halauthorid">1837168-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Roger</forename>
                <surname>Soll</surname>
              </persName>
              <idno type="halauthorid">3097925-0</idno>
            </author>
            <author role="aut">
              <persName>
                <forename type="first">Martin</forename>
                <surname>Offringa</surname>
              </persName>
              <idno type="halauthorid">567747-0</idno>
            </author>
            <editor role="depositor">
              <persName>
                <forename>KIM AN</forename>
                <surname>NGUYEN</surname>
              </persName>
              <email type="md5">79e9319abd65af88dbbcde042f02a016</email>
              <email type="domain">chu-lyon.fr</email>
            </editor>
          </titleStmt>
          <editionStmt>
            <edition n="v1" type="current">
              <date type="whenSubmitted">2024-06-09 23:26:15</date>
              <date type="whenModified">2025-02-24 15:24:03</date>
              <date type="whenReleased">2024-06-09 23:26:15</date>
              <date type="whenProduced">2023-09-01</date>
              <ref type="externalLink" target="http://irep.iium.edu.my/106827/7/106827_Strengthening%20reporting%20of%20neonatal%20trials_SCOPUS.pdf"/>
            </edition>
            <respStmt>
              <resp>contributor</resp>
              <name key="1038938">
                <persName>
                  <forename>KIM AN</forename>
                  <surname>NGUYEN</surname>
                </persName>
                <email type="md5">79e9319abd65af88dbbcde042f02a016</email>
                <email type="domain">chu-lyon.fr</email>
              </name>
            </respStmt>
          </editionStmt>
          <publicationStmt>
            <distributor>CCSD</distributor>
            <idno type="halId">hal-04606190</idno>
            <idno type="halUri">https://hal.science/hal-04606190</idno>
            <idno type="halBibtex">webbe:hal-04606190</idno>
            <idno type="halRefHtml">&lt;i&gt;Pediatrics&lt;/i&gt;, 2023, 152 (3), &lt;a target="_blank" href="https://dx.doi.org/10.1542/PEDS.2022-060765"&gt;&amp;#x27E8;10.1542/PEDS.2022-060765&amp;#x27E9;&lt;/a&gt;</idno>
            <idno type="halRef">Pediatrics, 2023, 152 (3), &amp;#x27E8;10.1542/PEDS.2022-060765&amp;#x27E9;</idno>
            <availability status="restricted"/>
          </publicationStmt>
          <seriesStmt>
            <idno type="stamp" n="CNRS">CNRS - Centre national de la recherche scientifique</idno>
            <idno type="stamp" n="UNIV-LYON1">Université Claude Bernard - Lyon I</idno>
            <idno type="stamp" n="LBBE" corresp="UNIV-LYON1">Laboratoire de biométrie et biologie évolutive </idno>
            <idno type="stamp" n="UDL">UDL</idno>
            <idno type="stamp" n="UNIV-LYON">Université de Lyon</idno>
            <idno type="stamp" n="TEST4-HALCNRS">collection test</idno>
            <idno type="stamp" n="INEE-CNRS">Institut écologie et environnement du CNRS</idno>
          </seriesStmt>
          <notesStmt>
            <note type="audience" n="2">International</note>
            <note type="popular" n="0">No</note>
            <note type="peer" n="1">Yes</note>
          </notesStmt>
          <sourceDesc>
            <biblStruct>
              <analytic>
                <title xml:lang="en">Strengthening Reporting of Neonatal Trials</title>
                <author role="aut">
                  <persName>
                    <forename type="first">James</forename>
                    <surname>Webbe</surname>
                  </persName>
                  <idno type="halauthorid">3169856-0</idno>
                  <affiliation ref="#struct-1200422"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Ami</forename>
                    <surname>Baba</surname>
                  </persName>
                  <idno type="halauthorid">3169857-0</idno>
                  <affiliation ref="#struct-167754"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Nancy</forename>
                    <surname>Butcher</surname>
                  </persName>
                  <idno type="halauthorid">2200846-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Craig</forename>
                    <surname>Rodrigues</surname>
                  </persName>
                  <idno type="halauthorid">3169858-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Emma</forename>
                    <surname>Stallwood</surname>
                  </persName>
                  <idno type="halauthorid">3169859-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Katherine</forename>
                    <surname>Goren</surname>
                  </persName>
                  <idno type="halauthorid">3169860-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Andrea</forename>
                    <surname>Monsour</surname>
                  </persName>
                  <idno type="halauthorid">3169861-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Alvin</forename>
                    <surname>Chang</surname>
                  </persName>
                  <idno type="halauthorid">3169862-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Amit</forename>
                    <surname>Trivedi</surname>
                  </persName>
                  <idno type="halauthorid">3169863-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Brett</forename>
                    <surname>Manley</surname>
                  </persName>
                  <idno type="halauthorid">3169864-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Emma</forename>
                    <surname>Mccall</surname>
                  </persName>
                  <idno type="halauthorid">3169865-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Fiona</forename>
                    <surname>Bogossian</surname>
                  </persName>
                  <idno type="halauthorid">3169866-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Fumihiko</forename>
                    <surname>Namba</surname>
                  </persName>
                  <idno type="halauthorid">3169867-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Georg</forename>
                    <surname>Schmölzer</surname>
                  </persName>
                  <idno type="halauthorid">3111804-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Himanshu</forename>
                    <surname>Popat</surname>
                  </persName>
                  <idno type="halauthorid">3097928-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Kim An</forename>
                    <surname>Nguyen</surname>
                  </persName>
                  <email type="md5">79e9319abd65af88dbbcde042f02a016</email>
                  <email type="domain">chu-lyon.fr</email>
                  <idno type="idhal" notation="string">nguyenan</idno>
                  <idno type="idhal" notation="numeric">1390361</idno>
                  <idno type="halauthorid" notation="string">1317202-1390361</idno>
                  <idno type="RESEARCHERID">http://www.researcherid.com/rid/AGT-1300-2022</idno>
                  <idno type="RESEARCHERID">http://www.researcherid.com/rid/http://www.researcherid.com/rid/AGT-1300-2022</idno>
                  <affiliation ref="#struct-10025"/>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Lex</forename>
                    <surname>Doyle</surname>
                  </persName>
                  <idno type="halauthorid">1777340-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Luke</forename>
                    <surname>Jardine</surname>
                  </persName>
                  <idno type="halauthorid">3169868-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Matthew</forename>
                    <surname>Rysavy</surname>
                  </persName>
                  <idno type="halauthorid">3169869-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Menelaos</forename>
                    <surname>Konstantinidis</surname>
                  </persName>
                  <idno type="halauthorid">3169870-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Muhd Alwi</forename>
                    <surname>Muhd Helmi</surname>
                  </persName>
                  <idno type="halauthorid">3169871-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Nai Ming</forename>
                    <surname>Lai</surname>
                  </persName>
                  <idno type="halauthorid">3169872-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Susanne</forename>
                    <surname>Hay</surname>
                  </persName>
                  <idno type="halauthorid">3169873-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Wes</forename>
                    <surname>Onland</surname>
                  </persName>
                  <idno type="halauthorid">3117977-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Yao Mun</forename>
                    <surname>Choo</surname>
                  </persName>
                  <idno type="halauthorid">3169874-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Chris</forename>
                    <surname>Gale</surname>
                  </persName>
                  <idno type="halauthorid">1837168-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Roger</forename>
                    <surname>Soll</surname>
                  </persName>
                  <idno type="halauthorid">3097925-0</idno>
                </author>
                <author role="aut">
                  <persName>
                    <forename type="first">Martin</forename>
                    <surname>Offringa</surname>
                  </persName>
                  <idno type="halauthorid">567747-0</idno>
                </author>
              </analytic>
              <monogr>
                <idno type="halJournalId" status="VALID">17834</idno>
                <idno type="issn">0031-4005</idno>
                <idno type="eissn">1098-4275</idno>
                <title level="j">Pediatrics</title>
                <imprint>
                  <publisher>American Academy of Pediatrics</publisher>
                  <biblScope unit="volume">152</biblScope>
                  <biblScope unit="issue">3</biblScope>
                  <date type="datePub">2023-09-01</date>
                </imprint>
              </monogr>
              <idno type="doi">10.1542/PEDS.2022-060765</idno>
            </biblStruct>
          </sourceDesc>
          <profileDesc>
            <langUsage>
              <language ident="en">English</language>
            </langUsage>
            <textClass>
              <classCode scheme="halDomain" n="sdv">Life Sciences [q-bio]</classCode>
              <classCode scheme="halTypology" n="ART">Journal articles</classCode>
              <classCode scheme="halOldTypology" n="ART">Journal articles</classCode>
              <classCode scheme="halTreeTypology" n="ART">Journal articles</classCode>
            </textClass>
            <abstract xml:lang="en">
              <p>BACKGROUND AND OBJECTIVES There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications. METHODS Neonatal trials including &amp;gt;100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports. RESULTS Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: “survival,” “short-term neonatal complications,” and “long-term developmental outcomes” depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting. CONCLUSIONS We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.</p>
            </abstract>
          </profileDesc>
        </biblFull>
      </listBibl>
    </body>
    <back>
      <listOrg type="structures">
        <org type="institution" xml:id="struct-1200422" status="INCOMING">
          <orgName>Neonatal Medicine, School of Public Health, Imperial College London</orgName>
          <desc>
            <address>
              <country key="GB"/>
            </address>
          </desc>
        </org>
        <org type="laboratory" xml:id="struct-167754" status="INCOMING">
          <orgName>Research Institute of the Hospital for Sick Children and University of Toronto</orgName>
          <desc>
            <address>
              <addrLine>555 University Avenue, Toronto, Ontario M5G 1X8</addrLine>
              <country key="CA"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-300722" type="direct"/>
          </listRelation>
        </org>
        <org type="laboratory" xml:id="struct-10025" status="VALID">
          <idno type="IdRef">15069671X</idno>
          <idno type="ISNI">0000000403863493</idno>
          <idno type="RNSR">199411998X</idno>
          <idno type="ROR">https://ror.org/03skt0t88</idno>
          <orgName>Laboratoire de Biométrie et Biologie Evolutive - UMR 5558</orgName>
          <orgName type="acronym">LBBE</orgName>
          <date type="start">1995-01-01</date>
          <desc>
            <address>
              <addrLine>43 Bld du 11 Novembre 1918 69622 VILLEURBANNE CEDEX</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://lbbe.univ-lyon1.fr/</ref>
          </desc>
          <listRelation>
            <relation active="#struct-194495" type="direct"/>
            <relation active="#struct-301088" type="indirect"/>
            <relation active="#struct-301767" type="direct"/>
            <relation name="UMR5558" active="#struct-441569" type="direct"/>
          </listRelation>
        </org>
        <org type="regroupinstitution" xml:id="struct-300722" status="VALID">
          <idno type="ROR">https://ror.org/03dbr7087</idno>
          <orgName>University of Toronto</orgName>
          <date type="start">1827-01-01</date>
          <desc>
            <address>
              <addrLine>27 King's College Circle, Toronto M5S 1A1</addrLine>
              <country key="CA"/>
            </address>
            <ref type="url">http://www.utoronto.ca/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-194495" status="VALID">
          <idno type="IdRef">026402823</idno>
          <idno type="ISNI">0000000121686185</idno>
          <idno type="ROR">https://ror.org/029brtt94</idno>
          <orgName>Université Claude Bernard Lyon 1</orgName>
          <orgName type="acronym">UCBL</orgName>
          <desc>
            <address>
              <addrLine>43, boulevard du 11 novembre 1918, 69622 Villeurbanne cedex</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.univ-lyon1.fr/</ref>
          </desc>
          <listRelation>
            <relation active="#struct-301088" type="direct"/>
          </listRelation>
        </org>
        <org type="regroupinstitution" xml:id="struct-301088" status="VALID">
          <idno type="ROR">https://ror.org/01rk35k63</idno>
          <orgName>Université de Lyon</orgName>
          <desc>
            <address>
              <addrLine>92 rue Pasteur - CS 30122, 69361 Lyon Cedex 07</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.universite-lyon.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-301767" status="VALID">
          <idno type="ROR">https://ror.org/01c7wz417</idno>
          <orgName>VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement</orgName>
          <orgName type="acronym">VAS</orgName>
          <date type="start">2010-01-01</date>
          <desc>
            <address>
              <addrLine>Université de Lyon, VetAgro Sup, 69280 Marcy l'Etoile (campus vétérinaire); Université de Clermont, VetAgro Sup, 63370 Lempdes (campus agronomique)</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.vetagro-sup.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-441569" status="VALID">
          <idno type="IdRef">02636817X</idno>
          <idno type="ISNI">0000000122597504</idno>
          <idno type="ROR">https://ror.org/02feahw73</idno>
          <orgName>Centre National de la Recherche Scientifique</orgName>
          <orgName type="acronym">CNRS</orgName>
          <date type="start">1939-10-19</date>
          <desc>
            <address>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.cnrs.fr/</ref>
          </desc>
        </org>
      </listOrg>
    </back>
  </text>
</TEI>