Skip Navigation

United States Department of Health & Human Services
line

Print Print    Download Reader PDF


 


Office for Human Research Protections (OHRP)

Precursor Preferences in Surfactant Synthesis of Newborns


Requesting IRB:

Washington University Medical Center

Study Summary:

The above-referenced research protocol proposes to administer to preterm and full-term newborns simultaneous 24-hour infusions of palmitate and acetate labeled with the stable (non-radioactive) isotope carbon-13, then measure the incorporation of each into surfactant, collected by tracheal aspiration. Subjects of the study would include approximately 10 full-term intubated infants with normal lungs and 15-20 preterm (24 to 28 weeks gestational age) intubated infants with respiratory distress syndrome. The overall goal of the proposed study is to better understand the potential differences in precursor preferences in surfactant synthesis between preterm infants with immature lungs (requiring mechanical ventilation) and term infants with normal lung function. The three specific aims of the study are to: (i) determine the rate of surfactant using synthesis de novo synthesizing fatty acids (acetate); (ii) determine the rate of surfactant synthesis using preformed fatty acids (palmitate); and (iii) compare the rates of incorporation in preterm infants versus term infants with normal lungs.

Funding Source:

National Heart, Lung, and Blood Institute, National Institutes of Health

OHRP Communications

IRB Communications to OHRP

Protocol Details

Parental Permission Documents

IRB Documents

Product Information

Other Communications and Documents

Federal Register Notices

Panel of Experts Transcripts


Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.

Last revised: April 24, 2006

spacer

HHS Home | Questions? | Contact HHS | Accessibility | Privacy Policy | FOIA | Disclaimers

The White House | USA.gov | HHS Archive | No FEAR Act