2005N-0184 Precursor Preference in Surfactant Synthesis of Newborns
FDA Comment Number : EC4
Submitter : Dr. Alexander Rakowsky Date & Time: 06/17/2005 10:06:07
Organization : Columbus Childrens Hospital
Category : Academia
Issue Areas/Comments
GENERAL
GENERAL
This study will require a 24 hour infusion of sterile, non-radioactive, stable isotopes in both the premature study subjects as well as in the infants with normal lungs.

It is assumed that the infants with normal lungs are intubated due to the existence of another medical condition that has made them unstable enough, clinically, so as to require intensive care.

Considering this, plus the difficulty in obtaining vascular access in newborns, I have the following questions:

1. Are there assurances in the protocol that this infusion will be discontinued IF a need for vascular access is required for the infusion of a medically necessary product?

2. What will be done with those infants for whom the 24 hour infusion was not completed? Will they be considered "ineligible" or have pharmacokinetic parameters been worked out for shorter infusion times? I am fearful that infants, both premature and those with healthy lungs, will be exposed to multiple hours of infusion, but due to failing to reach the full 24 hour infusion time, will have had this done for naught.

3. What are the potential complications of having the isotope infusion extravasate due to a leak in the vascular access?

4. What are the potential interactions of the isotope infusion if accidently infused together with such common NICU products as hyperalimentation, pressors, saline, blood products, etc.


I realize that many of these questions may have already been answered in the ful protocol. However, I did not have access to this.

Thank you for consideration of these comments.


Alexander Rakowsky, M.D.
IRB Chair
Columbus Childrens Hospital
Columbus Ohio