Medico-legal implications of hypothermic neuroprotection in the newborn.

Hypoxic-ischemic encephalopathy (HIE) continues to be a significant source of long term neurological sequelae in infants born at or near term. In the past decade, selective head or whole body cooling has shown promising benefit in ameliorating some of the brain injury from intrapartum asphyxial insults and has become standard care in most developed countries. A decision to offer neuroprotective hypothermia (NPH) may engender subsequent litigation because it presupposes an acute intrapartum injury. Conversely, failing to offer cooling may be interpreted as a violation in the standard of care. In this paper, we review the clinical aspects of NPH and the medico-legal scenarios often seen after acute birth injury.

Multiples and parents of multiples prefer same arm randomization of siblings in neonatal trials.

OBJECTIVE: Although common among Neonatal Intensive Care Units, multiples births are randomized inconsistently within trials, which can impact enrollment, analytical approach and trial outcomes. It is not known what randomization approach (same arm, different arm and independent randomization) is preferred by multiples and their families. STUDY DESIGN: Surveys distributed to parents of multiples and adult multiples addressed the preferences on randomization by eliciting the most desired method and likelihood of enrolling twins for each randomization approach. RESULT: Populations included 209 parents and 321 adult multiples. Seventy-eight percent of parents and 59% of multiples prefer same arm placement of multiples over other methods (both P<0.001), which also had highest likelihood of enrollment among both the groups. CONCLUSION: Parents of multiples and adult multiples prefer placement of multiples into same treatment arm in randomized trials, making such methodology a potential way to optimize consent rates while ethically approaching human subject research.