Instructions for Trial Summary Submission

Please use the format below to describe your trial.

Keep in mind the intent of your summary is to provide a concise overview of your study to initiate the interest of other potential collaborators. It should not attempt to provide an exhaustive description; your full protocol should be available upon request for interested parties.

Notes and Disclaimer:

• You may send this by e-mail to markovitz@pedsccm.org as plain text or as an attachment (Microsoft Word 97/98 preferred)
• All submissions are peer reviewed for evidence of scientific merit, pertinence to the Pediatric Critical Care community, and clarity. (However, PedsCCM does not review the full proposals and assumes no responsibility for errors, omissions, or misrepresentations.)
• PedsCCM is serving solely as a "clearinghouse" for such trials, and, unless otherwise stated, is under no fiduciary arrangement with PI's or sponsors of trials listed herein.

Study Title

Principal Investigator:

Name, degree

Full name and address of primary institution

E Mail address of PI

Phone and fax number of PI

Introduction and Aims

A concise summary of background information and specific aims of the project. The project design, e.g., randomized trial, retrospective review, etc., should be noted. (2-3 paragraphs)

Inclusion Criteria:

Specify inclusion criteria. (1 paragraph)

Exclusion Criteria:

Specify exclusion criteria. (1 paragraph)

Protocol:

A concise summary of the study protocol, including treatment assignment, data collection, and study endpoint(s), as appropriate. (1-2 paragraphs)

Data Analysis:

Delineation of primary and secondary outcome variables, with an estimate of sample size, as appropriate. (1 paragraph)

Notes:

Additional features of the study, such as estimates of time and resource commitment needed, available funding, or other special requirements of note. (brief list)