Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial).

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Title: Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial).
Authors: Poppe JA; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands., Flint RB; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands., Smits A; Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium., Willemsen SP; Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands., Storm KK; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands., Nuytemans DH; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands., Onland W; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands., Poley MJ; Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center Sophia Children's Hospital, Rotterdam, the Netherlands.; Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, the Netherlands., de Boode WP; Department of Neonatology, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, the Netherlands., Carkeek K; Neonatal Intensive Care Unit, Cliniques Universitaires Saint Luc, Brussels, Belgium., Cassart V; Department of Neonatology, Grand hôpital de Charleroi, Charleroi, Belgium., Cornette L; Department Neonatology, AZ St-Jan, Bruges, Belgium., Dijk PH; Division of Neonatology, Department of Paediatrics, Beatrix Children's Hospital, University Medical Centre Groningen, Groningen, the Netherlands., Hemels MAC; Department of Neonatology, Isala, Zwolle, Zwolle, the Netherlands., Hermans I; Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium., Hütten MC; Division of Neonatology, Department of Pediatrics, Maastricht University Medical Center, Maastricht, the Netherlands., Kelen D; Neonatal Department, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium., de Kort EHM; Division of Neonatology, Department of Pediatrics, Máxima Medical Center, Veldhoven, the Netherlands., Kroon AA; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands., Lefevere J; Neonatology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium., Plaskie K; Department of Neonatology, GasthuisZusters Antwerpen, Antwerp, Belgium., Stewart B; Quality Management in Clinical Research (QMCR), University of Alberta, Edmonton, AB, Canada., Voeten M; Department of Neonatal Intensive Care, University Hospital Antwerp, Edegem, Belgium., van Weissenbruch MM; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands., Williams O; Neonatology and Neonatal Intensive Care Unit, CHIREC-Delta Hospital, Brussels, Belgium., Zonnenberg IA; Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands., Lacaze-Masmonteil T; Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Maternal Infant Child & Youth Research Network (MICYRN), Vancouver, Canada., Pas ABT; Division of Neonatology, Department of Paediatrics, Willem-Alexander Children's Hospital, Leiden University Medical Centre, Leiden, the Netherlands., Reiss IKM; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands., van Kaam AH; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands., Allegaert K; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.; Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium., Hutten GJ; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands., Simons SHP; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands. s.simons@erasmusmc.nl.
Source: Trials [Trials] 2023 Oct 10; Vol. 24 (1), pp. 656. Date of Electronic Publication: 2023 Oct 10.
Publication Type: Clinical Trial Protocol; Journal Article
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial).
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  Data: <searchLink fieldCode="AU" term="%22Poppe+JA%22">Poppe JA</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Flint+RB%22">Flint RB</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Smits+A%22">Smits A</searchLink>; Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Willemsen+SP%22">Willemsen SP</searchLink>; Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Storm+KK%22">Storm KK</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Nuytemans+DH%22">Nuytemans DH</searchLink>; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Onland+W%22">Onland W</searchLink>; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Poley+MJ%22">Poley MJ</searchLink>; Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center Sophia Children's Hospital, Rotterdam, the Netherlands.; Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22de+Boode+WP%22">de Boode WP</searchLink>; Department of Neonatology, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Carkeek+K%22">Carkeek K</searchLink>; Neonatal Intensive Care Unit, Cliniques Universitaires Saint Luc, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Cassart+V%22">Cassart V</searchLink>; Department of Neonatology, Grand hôpital de Charleroi, Charleroi, Belgium.<br /><searchLink fieldCode="AU" term="%22Cornette+L%22">Cornette L</searchLink>; Department Neonatology, AZ St-Jan, Bruges, Belgium.<br /><searchLink fieldCode="AU" term="%22Dijk+PH%22">Dijk PH</searchLink>; Division of Neonatology, Department of Paediatrics, Beatrix Children's Hospital, University Medical Centre Groningen, Groningen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hemels+MAC%22">Hemels MAC</searchLink>; Department of Neonatology, Isala, Zwolle, Zwolle, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hermans+I%22">Hermans I</searchLink>; Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Hütten+MC%22">Hütten MC</searchLink>; Division of Neonatology, Department of Pediatrics, Maastricht University Medical Center, Maastricht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Kelen+D%22">Kelen D</searchLink>; Neonatal Department, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22de+Kort+EHM%22">de Kort EHM</searchLink>; Division of Neonatology, Department of Pediatrics, Máxima Medical Center, Veldhoven, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Kroon+AA%22">Kroon AA</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Lefevere+J%22">Lefevere J</searchLink>; Neonatology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Plaskie+K%22">Plaskie K</searchLink>; Department of Neonatology, GasthuisZusters Antwerpen, Antwerp, Belgium.<br /><searchLink fieldCode="AU" term="%22Stewart+B%22">Stewart B</searchLink>; Quality Management in Clinical Research (QMCR), University of Alberta, Edmonton, AB, Canada.<br /><searchLink fieldCode="AU" term="%22Voeten+M%22">Voeten M</searchLink>; Department of Neonatal Intensive Care, University Hospital Antwerp, Edegem, Belgium.<br /><searchLink fieldCode="AU" term="%22van+Weissenbruch+MM%22">van Weissenbruch MM</searchLink>; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Williams+O%22">Williams O</searchLink>; Neonatology and Neonatal Intensive Care Unit, CHIREC-Delta Hospital, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Zonnenberg+IA%22">Zonnenberg IA</searchLink>; Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Lacaze-Masmonteil+T%22">Lacaze-Masmonteil T</searchLink>; Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.; Maternal Infant Child & Youth Research Network (MICYRN), Vancouver, Canada.<br /><searchLink fieldCode="AU" term="%22Pas+ABT%22">Pas ABT</searchLink>; Division of Neonatology, Department of Paediatrics, Willem-Alexander Children's Hospital, Leiden University Medical Centre, Leiden, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Reiss+IKM%22">Reiss IKM</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Kaam+AH%22">van Kaam AH</searchLink>; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Allegaert+K%22">Allegaert K</searchLink>; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.; Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Hutten+GJ%22">Hutten GJ</searchLink>; Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.; Amsterdam Reproduction & Development, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Simons+SHP%22">Simons SHP</searchLink>; Department of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center Sophia Children's Hospital, Room Sk-4113, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands. s.simons@erasmusmc.nl.
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  Data: <searchLink fieldCode="JN" term="%22101263253%22">Trials</searchLink> [Trials] 2023 Oct 10; Vol. 24 (1), pp. 656. <i>Date of Electronic Publication: </i>2023 Oct 10.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101263253 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1745-6215 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217456215%22">17456215 </searchLink><i>NLM ISO Abbreviation: </i>Trials <i>Subsets: </i>MEDLINE
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