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.

Assessment of resistance of nasal continuous positive airway pressure interfaces.

OBJECTIVE: To compare the resistance of interfaces used for the delivery of nasal continuous positive airway pressure (CPAP) in neonates, as measured by the generated system pressure at fixed gas flows, in an in vitro setting. DESIGN: Gas flows of 6, 8 and 10 L/min were passed through three sizes of each of a selection of available neonatal nasal CPAP interfaces (Hudson prong, RAM Cannula, Fisher & Paykel prong, Infant Flow prong, Fisher & Paykel mask, Infant Flow mask). The expiratory limb was occluded and pressure differential measured using a calibrated pressure transducer. RESULTS: Variation in resistance, assessed by mean pressure differential, was seen between CPAP interfaces. Binasal prong interfaces typically had greater resistance at the smallest assessed sizes, and with higher gas flows. However, Infant Flow prongs produced low pressures (<1.5 cmH2O) at all sizes and gas flows. RAM Cannula had a high resistance, producing a pressure >4.5 cmH2O at all sizes and gas flows. Both nasal mask interfaces had low resistance at all assessed sizes and gas flows, with recorded pressure <1 cmH2O in all cases. CONCLUSIONS: There is considerable variation in measured resistance of available CPAP interfaces at gas flows commonly applied in clinical neonatal care. Use of interfaces with high resistance may result in a greater drop in delivered airway pressure in comparison to set circuit pressure, which may have implications for clinical efficacy. Device manufacturers and clinicians should consider CPAP interface resistance prior to introduction into routine clinical care.