2005N-0184 Precursor Preference in Surfactant Synthesis of Newborns
FDA Comment Number : EC2
Submitter : Dr. Jon Ebbert Date & Time: 06/17/2005 10:06:44
Organization : Dr. Jon Ebbert
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Dr. Spence makes a compelling rationale for conducting this study and has strong preliminary data. The following comment is in regard to the "Relevant Excerpts from the Grant Application." At question is the safety of these infusions. Little information has been provided regarding the concomitant medical conditions, outcomes, and possible adverse effects experienced by the 60 infants who have reportedly undergone stable isotope infusion at Washington University. Unfortunatley, I could not find the manuscript that has been submitted for review on this experience - a thorough review of that may supply this information. Further, while the invidual constituents of the infusion are safe, it is not clear that the research team has infused precisely the same infusion that they are proposing to infuse in the current proposal. Further, does this continuous infusion potentially come at the cost of the infusion of other life-saving crystalloids or oncotics. This needs to be clarified to ensure the safety of the otherwise healthy infants being asked to participate in this study.