Permissive hypercapnia in extremely low birthweight infants (PHELBI)

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Half of the 4000 extremely low birthweight infants born in Germany every year develop bronchopulmonary dysplasia (BPD) or die during infancy, resulting in a significant burden. Because the life-saving mechanical ventilation is partly responsible for the lung injury, more gentle ventilation with lower tidal volumes may significantly reduce the incidence of BPD, but will be associated with higher arterial partial pressure of carbon dioxide (PaCO2) values. Accepting higher PaCO2 values without increasing ventilator settings may therefore lead to lower tidal volumes and more gentle mechanical ventilation but may also increase cerebral blood flow and the risk for intracranial hemorrhages. All previous clinical trials testing this approach, however, were hampered by insufficient sample sizes and very small PaCO2 differences between study groups, and failed to demonstrate clear benefits. Despite the lack of sound efficacy and safety data, higher PaCO2 targets have been increasingly used in many neonatal intensive care units. Therefore, a well-designed trial is urgently needed. We propose to perform a multicenter trial randomizing more than twice as many infants as the largest study performed till now to two strongly different PaCO2 target ranges. This trial will answer the open questions and profoundly influence neonatal clinical care worldwide, as the findings can be immediately implemented.