Observational study of parental opinion of deferred consent for neonatal research.

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

Neonatal mannequin comparison of the Upright self-inflating bag and snap-fit mask versus standard resuscitators and masks: leak, applied load and tidal volumes.

OBJECTIVE: Neonatal mask ventilation is a difficult skill to acquire and maintain. Mask leak is common and can lead to ineffective ventilation. The aim of this study was to determine whether newly available neonatal self-inflating bags and masks could reduce mask leak without additional load being applied to the face. DESIGN: Forty operators delivered 1 min episodes of mask ventilation to a mannequin using the Laerdal Upright Resuscitator, a standard Laerdal infant resuscitator (Laerdal Medical) and a T-Piece Resuscitator (Neopuff), using both the Laerdal snap-fit face mask and the standard Laerdal size 0/1 face mask (equivalent sizes). Participants were asked to use pressure sufficient to achieve 'appropriate' chest rise. Leak, applied load, airway pressure and tidal volume were measured continuously. Participants were unaware that load was being recorded. RESULTS: There was no difference in mask leak between resuscitation devices. Leak was significantly lower when the snap-fit mask was used with all resuscitation devices, compared with the standard mask (14% vs 37% leak, P<0.01). The snap-fit mask was preferred by 83% of participants. The device-mask combinations had no significant effect on applied load. CONCLUSIONS: The Laerdal Upright Resuscitator resulted in similar leak to the other resuscitation devices studied, and did not exert additional load to the face and head. The snap-fit mask significantly reduced overall leak with all resuscitation devices and was the mask preferred by participants.