TY - JOUR T1 - Highlights from this issue JF - Archives of Disease in Childhood - Fetal and Neonatal Edition JO - Arch Dis Child Fetal Neonatal Ed SP - 115 LP - 115 DO - 10.1136/archdischild-2021-321797 VL - 106 IS - 2 AU - Ben J Stenson Y1 - 2021/03/01 UR - http://fn.bmj.com/content/106/2/115.abstract N2 - Vohra and colleagues report secondary information from their trial of heat loss prevention with polyethylene wrap. The focus of their report is to show that the two models for enrolment that were used resulted in the inclusion of populations of infants that were different. The main method of inclusion in the trial followed the obtaining of antenatal informed parental consent. In four centres, approval was granted for the inclusion of infants without prior consent. Compared with babies enrolled after antenatal consent, a smaller proportion of babies enrolled without prior consent were born to mothers who had received antenatal steroids. More of the mothers whose babies were enrolled without prior consent were college educated. The babies recruited without prior consent had lower Apgar scores. These are not the first authors to note the impact of different consent procedures on the characteristics of the infants enrolled. Similar observations were made in the SUPPORT Trial.1 This phenomenon is scientifically important and is discussed in detail by Vohra and colleagues and in an accompanying editorial by Louise Owen and Peter Davis. Researching the effect of interventions that begin close to birth is very challenging and the traditional model of prior informed consent slows recruitment, results in the enrolment of biased populations with different risk profiles, and decreases the generalisability of the results obtained. Conducted properly, research without prior consent aims to … ER -