RT Journal Article
SR Electronic
T1 Differences in demographics and outcomes based on method of consent for a randomised controlled trial on heat loss prevention in the delivery room
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 118
OP 124
DO 10.1136/archdischild-2020-319045
VO 106
IS 2
A1 Sunita Vohra
A1 Maureen Reilly
A1 Valeria E Rac
A1 Zafira Bhaloo
A1 Denise Zayak
A1 John Wimmer
A1 Michael Vincer
A1 Karla Ferrelli
A1 Alex Kiss
A1 Roger Soll
A1 Michael Dunn
YR 2021
UL http://fn.bmj.com/content/106/2/118.abstract
AB 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.