Competing interests {28}
The study investigators have no financial conflicts of interest (FCOI) related to the study outlined in this protocol. We will handle any potential or perceived conflicts of interest, including FCOI, per Title 42, Code of Federal Regulations, Part 50, Subpart F (50.604 Responsibilities of Institutions regarding Investigator financial conflicts of interest). This states that institutional officials (and all subrecipients) are required to notify the grants officer of any FCOI prior to expenditure of any funds and within 60 days of any subsequently identified FCOI. The research team will simultaneously notify NICHD, ECHO office, the NRN Steering Committee, and the ISPCTN Steering Committee regarding the COI management plan, following institutional guidelines of each participating hospital.