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Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room
  1. Sunita Vohra1,
  2. Maureen Reilly2,
  3. Valeria E Rac2,3,
  4. Zafira Bhaloo1,
  5. Denise Zayak4,
  6. John Wimmer5,
  7. Michael Vincer6,
  8. Karla Ferrelli4,
  9. Alex Kiss3,7,
  10. Roger Soll4,8,
  11. Michael Dunn2,9
  1. 1 Pediatrics, University of Alberta, Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada
  2. 2 Women and Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  3. 3 Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  4. 4 Newborn-Perinatal Medicine, Vermont Oxford Network, Burlington, Vermont, USA
  5. 5 Cone Health, Women's Hospital of Greensboro, Greensboro, North Carolina, USA
  6. 6 Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada
  7. 7 Research Design and Biostatistics, Sunnybrook Research Institute, Toronto, Ontario, Canada
  8. 8 Pediatrics, University of Vermont, Burlington, Vermont, USA
  9. 9 Pediatrics, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Maureen Reilly, Women & Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; maureen.reilly{at}sunnybrook.ca

Abstract

Objective Informed consent is standard in research. International guidelines allow for research without prior consent in emergent situations, such as neonatal resuscitation. Research without prior consent was incorporated in the Vermont Oxford Network Heat Loss Prevention Trial. We evaluated whether significant differences in outcomes exist based on the consent method.

Design Subgroup analysis of infants enrolled in a randomised controlled trial conducted from 2004 to 2010.

Setting A multicentre trial with 38 participating centres.

Participants Infants born 24–27 weeks of gestation. 3048 infants assessed, 2231 excluded due to fetal congenital anomalies, failure to obtain consent or gestation less than 24 weeks. 817 randomised, 4 withdrew consent, total of 813 analysed.

Main outcome measure The difference in mortality between consent groups.

Results No significant differences were found in mortality at 36 weeks (80.2%, 77.4%, p=0.492) or 6 months corrected gestational age (80.7%, 79.7%, p=0.765). Infants enrolled after informed consent were more likely to have mothers who had received antenatal steroids (95.2%, 84.0%, p<0.0001). They also had significantly higher Apgar scores at 1 (5.0, 4.4, p=0.019), 5 (7.3, 6.7, p=0.025) and 10 min (7.5, 6.3, p=0.0003).

Conclusions and relevance Research without prior consent resulted in the inclusion of infants with different baseline characteristics than those enrolled after informed consent. There were no significant differences in mortality. Significantly higher Apgar scores in the informed consent group suggest that some of the sicker infants would have been excluded from enrolment under informed consent. Research without prior consent should be considered in neonatal resuscitation research.

  • ethics
  • general paediatrics
  • paediatric practice
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Footnotes

  • Funding Funded by the Canadian Institutes of Health Research (MCT 71137 HELP Vohra) and the Stollery Children’s Hospital Foundation (Edmonton, Canada; G599000746). SV receives salary support as an Alberta Innovates-Health Solutions Health Scholar (G118160495). RS receives salary support as the director of trials and follow-up at Vermont Oxford Network.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be available upon request.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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