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Up-date on the NeoVitaA Trial: Obstacles, challenges, perspectives, and local experiences

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Summary

The aim of the NeoVitaA Trial is to assess the role of postnatal additional high-dose oral vitamin A supplementation for 28 days in reducing Bronchopulmonary dysplasia (BPD) or death in extremely low birth weight (ELBW) infants at 36 weeks postmenstrual age (PMA). All infants (both intervention and control group) will be provided with basic vitamin A (1000 IU/kg/day) in addition to trial intervention.

In this short communication, we will give an up-date on obstacles, challenges as well as perspectives and potential solutions when putting into place a multicenter, double-blind, randomized trial in this cohort of extremely susceptible infants.

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Fig. 1

Abbreviations

BPD:

Bronchopulmonary dysplasia

CPAP:

Continuous positive airway pressure

DGKJ:

Deutsche Gesellschaft für Kinderheilkunde und Jugendmedizin

ELBW:

Extremely low birth weight

GNPI:

Gesellschaft für Neonatologische und Pädiatrische Intensivmedizin

HFOV:

High frequency oscillatory ventilation

iNO:

inhalative nitric oxide

IZKS:

Interdisziplinäres Zentrum für Klinische Studien (Mainz)

NICHD:

National Institute of Child Health and Human Development

PMA:

Postmenstrual age

PPV:

Positive pressure ventilation

PPS:

Positive pressure support

RCT:

Randomized controlled trial

ZKS:

Zentrum für Klinische Studien (Tübingen)

References

  1. Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163:1723–9.

    Article  CAS  PubMed  Google Scholar 

  2. Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF, Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the Trial of Indomethacin Prophylaxis in Preterms. JAMA. 2003;289:1124–9.

    Article  PubMed  Google Scholar 

  3. Marter LJ van, Kuban KC, Allred E, Bose C, Dammann O, O’Shea M, Laughon M, Ehrenkranz RA, Schreiber MD, Karna P, Leviton A, ELGAN Study Investigators. Does bronchopulmonary dysplasia contribute to the occurrence of cerebral palsy among infants born before 28 weeks of gestation? Arch Dis Child Fetal Neonatal Ed. 2011;96:F20–F29.

    Article  PubMed  Google Scholar 

  4. Stichtenoth G, Demmert M, Bohnhorst B, Stein A, Ehlers S, Heitmann F, Rieger-Fackeldey E, Olbertz D, Roll C, Emeis M, Mögel M, Schiffmann H, Wieg C, Wintgens J, Herting E, Göpel W, Härtel C. Major contributors to hospital mortality in very-low-birth-weight infants: data of the birth year 2010 cohort of the German Neonatal Network. Klin Padiatr. 2012;224:276–81.

    Article  CAS  PubMed  Google Scholar 

  5. Gortner L, Misselwitz B, Milligan D, et al. Rates of bronchopulmonary dysplasia in very preterm neonates in Europe: results from the MOSAIC cohort. Neonatology. 2011;99:112–7.

    Article  PubMed  Google Scholar 

  6. Smith VC, Zupancic JA, McCormick MC, Croen LA, Greene J, Escobar GJ, Richardson DK. Trends in severe bronchopulmonary dysplasia rates between 1994 and 2002. J Pediatr. 2005;146:469–73.

    Article  PubMed  Google Scholar 

  7. Thomas W, Speer CP. Management of infants with bronchopulmonary dysplasia in Germany. Early Hum Dev. 2005;81:155–63.

    Article  PubMed  Google Scholar 

  8. Mercier JC, Hummler H, Durrmeyer X, Sanchez-Luna M, Carnielli V, Field D, Greenough A, Overmeire B van, Jonsson B, Hallman M, Baldassarre J, EUNO Study Group. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet. 2010;376:346–54.

    Article  CAS  PubMed  Google Scholar 

  9. Watterberg KL, American Academy of Pediatrics. Committee on fetus and newborn policy statement – postnatal corticosteroids to prevent or treat bronchopulmonary dysplasia. Pediatrics. 2010;126:800–8.

    Article  PubMed  Google Scholar 

  10. Röhr SB, Sauer H, Gortner L, Gräber S, Meyer S. Cardiovascular and metabolic side effects associated with hydrocortisone and dexamethasone use in VLBW infants: a single-centre experience. Acta Paediatr. 2013;102:e436.

    Article  PubMed  Google Scholar 

  11. Biesalski HK, Nohr I. Importance of vitamin A for lung function and development. Mol Aspects Med. 2003;24:431–40.

    Article  CAS  PubMed  Google Scholar 

  12. Metzler MD, Snyder JM. Retinoic acid differentially regulates expression of surfactant associated proteins in human fetal lung. Endocrinology. 1993;133:1990–8.

    Article  CAS  PubMed  Google Scholar 

  13. Zile MH. Function of vitamin A in vertebrate embryonic development. J Nutr. 2001;131:705–8.

    CAS  PubMed  Google Scholar 

  14. Darlow BA, Graham PJ. Vitamin A supplementation to prevent mortality and short- and long-term morbidity in very low birthweight infants. Cochrane Database Syst Rev. 2011;10:CD000501.

    Google Scholar 

  15. Tyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA, Stoll BJ, Lemons JA, Stevenson DK, Bauer CR, Korones SB, Fanaroff AA. Vitamin A supplementation for extremely-low-birth-weight infants. N Engl J Med. 1999;340:1962–8.

    Article  CAS  PubMed  Google Scholar 

  16. Kaplan HC, Tabangin ME, McClendon D, Meinzen-Derr J, Margolis PA, Donovan EF. Understanding variation in vitamin A supplementation among NICUs. Pediatrics. 2010;126:e367–e373.

    Article  PubMed  Google Scholar 

  17. Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, et al. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2009;50:85–91.

    Article  Google Scholar 

  18. Wardle SP, Hughes A, Chen S, Shaw NJ. Randomised controlled trial of oral vitamin A supplementation in preterm infants to prevent chronic lung disease. Arch Dis Child Fetal Neonatal Ed. 2001;84:F9–F13.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Gadhia MM, Cutter GR, Abman SH, Kinsella JP. Effects of early inhaled nitric oxide therapy and vitamin A supplementation on the risk for bronchopulmonary dysplasia in premature newborns with respiratory failure. J Pediatr. 2014;164:744–8.

    Article  CAS  PubMed  Google Scholar 

  20. Meyer S, Gortner L. NeoVitaA Trial Investigators Early postnatal additional high-dose oral vitamin A supplementation versus placebo for 28 days for preventing bronchopulmonary dysplasia or death in extremely low birth weight infants. Neonatology. 2014;105:182–8.

    Article  CAS  PubMed  Google Scholar 

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Collaborators

NeoVitaA Trial investigators: Sascha Meyer, Johannes Bay, Ludwig Gortner; IZKS Mainz: Anne Ehrlich, Christian Ruckes; Elisabeth-Children’s Hospital Oldenburg: Jürgen Seidenberg, Julia Muyimbwa; Children’s Hospital Aschaffenburg: Christian Wieg, Oliver Stangl; Department of Pediatrics, University of Magdeburg: Ralf Böttger, Stefan Avenarius; University Children’s Hospital Erlangen: Thomas Völkl, Hans-Georg Topf; University Children’s Hospital, RWTH Aachen: Konrad Heimann, Sonja Trepels-Kottek; Children’s Hospital Barmherzige Brüder Regensburg: Annette Keller-Wackerbauer, Jochen Kittel; Children’s Hospital Mutterhaus, Trier: Wolfgang Thomas, Andrea Czoske; University Children’s Hospital of Munich: Orsolya Genzel-Boroviczény, Raquel Mata Fernandez; University Children’s Hospital of Münster: Torsten Ott, Claudius Werner; University Children’s Hospital of Münster: Ursula Felderhoff-Müser, Anja Stein; Evangelical Children’s Hospital of Oberhausen: Eva Hahn, Andreas Jenke; Helios Hospital Wiesbaden: Jaqueline Bauer, Markus Knuf; Winterberg Hospital Saarbrücken: Donald Wurm, Jens Möller; Universitätsklinikum Heidelberg: Bernd Beedgen, Johannes Pöschl; Westpfalz Klinikum Kaiserslautern: Kathrin Fritsche, Claudia Jung; Neonatal Intensive Care Unit, University Children´s Hospital Bonn: Andreas Müller, Lars Wenzing; Universitätskinderklinik Bochum: Susanne Wiegand, Norbert Teig; Neonatal Intensive Care Unit, University Children´s Hospital Tübingen: Axel Franz, Christian Poets; Universitätskinderklinik Leipzig: Corinna Gebauer, Ulrich Thome; Department of Pediatrics and Adolescent Medicine, Medical University of Vienna: Angelika Berger, Alexandra Kreissl; Sana Klinikum Duisburg: Tina Mönig, Francisco Brevis Nuñez; Helios Klinikum Wuppertal: Stephan Lysko, Gediz Taskaya; Diakonie Klinikum Dattelsau, Nürnberg: Nicole Holzgartner, Michael Schroth; Department für Kinder- und Jugendheilkunde, Medizinische Universität Innsbruck: Ursula Kiechl, Vera Neubauer; NICU Marburg: Michael Zemlin, Rolf F. Maier; NICU Gießen: Harald Ehrhardt, Lars Klein; Neonatal Intensive Care Unit, University Children’s Hospital Mannheim: Julia Reinhard, Thomas Schaible; Zentrum für Kinder- und Jugendmedizin, Neonatologische und Pädiatrische Intensivmedizin; Universität Greifswald: Knud Linnemann, Matthias Heckmann; Institute for Medical Biometry, Epidemiology and Medical Informatics, Saarland University, Campus Homburg: Stefan Wagenpfeil; University Hohenheim, Stuttgart: Hans Konrad Biesalski, Donatus Nohr

Author information

Authors and Affiliations

  1. Neonatal Unit, University Hospital of Saarland, Building 9, 66421, Homburg, Germany

    Sascha Meyer &  Ludwig Gortner

Authors
  1. Sascha Meyer
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  2. Ludwig Gortner
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Consortia

NeoVitaA Trial investigators

  • Sascha Meyer
  • , Johannes Bay
  • , Ludwig Gortner
  • , Anne Ehrlich
  • , Christian Ruckes
  • , Jürgen Seidenberg
  • , Julia Muyimbwa
  • , Christian Wieg
  • , Oliver Stangl
  • , Ralf Böttger
  • , Stefan Avenarius
  • , Thomas Völkl
  • , Hans-Georg Topf
  • , Konrad Heimann
  • , Sonja Trepels-Kottek
  • , Annette Keller-Wackerbauer
  • , Jochen Kittel
  • , Wolfgang Thomas
  • , Andrea Czoske
  • , Orsolya Genzel-Boroviczény
  • , Raquel Mata Fernandez
  • , Torsten Ott
  • , Claudius Werner
  • , Ursula Felderhoff-Müser
  • , Anja Stein
  • , Eva Hahn
  • , Andreas Jenke
  • , Jaqueline Bauer
  • , Markus Knuf
  • , Donald Wurm
  • , Jens Möller
  • , Bernd Beedgen
  • , Johannes Pöschl
  • , Kathrin Fritsche
  • , Claudia Jung
  • , Andreas Müller
  • , Lars Wenzing
  • , Susanne Wiegand
  • , Norbert Teig
  • , Axel Franz
  • , Christian Poets
  • , Corinna Gebauer
  • , Ulrich Thome
  • , Angelika Berger
  • , Alexandra Kreissl
  • , Tina Mönig
  • , Francisco Brevis Nuñez
  • , Stephan Lysko
  • , Gediz Taskaya
  • , Nicole Holzgartner
  • , Michael Schroth
  • , Ursula Kiechl
  • , Vera Neubauer
  • , Michael Zemlin
  • , Rolf F. Maier
  • , Harald Ehrhardt
  • , Lars Klein
  • , Julia Reinhard
  • , Thomas Schaible
  • , Knud Linnemann
  • , Matthias Heckmann
  • , Stefan Wagenpfeil
  • , Hans Konrad Biesalski
  •  & Donatus Nohr

Corresponding author

Correspondence to Sascha Meyer.

Ethics declarations

Conflict of interest

S. Meyer, L. Gortner, and the NeoVitaA Trial investigators declare that they have no competing interests. The manuscript has been seen and approved by all contributing authors.

Ethical standards

The study has also been approved by all relevant state committees and local ethics committees.

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Meyer, S., Gortner, L. & NeoVitaA Trial investigators. Up-date on the NeoVitaA Trial: Obstacles, challenges, perspectives, and local experiences. Wien Med Wochenschr 167, 264–270 (2017). https://doi.org/10.1007/s10354-016-0500-z

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  • DOI: https://doi.org/10.1007/s10354-016-0500-z

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