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Study Name: Infant Formula Fortified with DHA
Study Type: Interventional
Intervention Category: Anti-Inflammatory
Study Sponsor: O'Sullivan, Brian

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Docosahexaenoic Acid (DHA)
Number of Participants Being Recruited: 100
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study is to see if feeding infants diagnosed with CF through newborn screening with a formula fortified with DHA (specific fats not present in standard infant formulas) can slow damage from CF. The fats in this study are in human breast milk and may add to the improved health seen in CF infants who are breast fed. Infants who are not breast fed will be enrolled and randomly assigned to receive either standard or supplemented formula. Infants will be followed until 1 year of age.
ELIGIBILITY
Age: 1 Days - 56 Days
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: O'Sullivan, Brian
(508) 856-4155
OSullivb@ummhc.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00530244?term=formula+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
DE
  • Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
    Contact Information:
        Budd, Sandra
        Phone: (302) 651-6536
        Email: sbudd@nemours.org
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
KS
  • Via Christi - Saint Francis Campus (Pediatric), Wichita, KS, 67214
    Contact Information:
        Miller, Sheri
        Phone: (316) 268-6028
        Email: Sheri.Miller@viachristi.org
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
  • University of Massachusetts Memorial Health Care (Pediatric), Worcester, MA, 01655
    Contact Information:
        Longtine, Karen
        Phone: (508) 856-6970
        Email: Karen.Longtine@umassmed.edu
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
NY
  • Albany Medical College (Pediatric), Albany, NY, 12208
    Contact Information:
        Evans, Terese
        Phone: (518) 262-5293
        Email: evansmt@mail.amc.edu
  • Women and Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
    Contact Information:
        Caci, Nadine
        Phone: (716) 878-7524
        Email: ncaci@upa.chob.edu
  • The Steven & Alexandra Cohen Children's Medical Center of New York (Pediatric), Great Neck, NY, 11021
    Contact Information:
        Galvin, Susan
        Phone: (516) 622-5281
        Email: sgalvin@nshs.edu
  • University of Rochester Medical Center Strong Memorial (Pediatric), Rochester, NY, 14642
    Contact Information:
        Nix, Nancy
        Phone: (585) 275-8580
        Email: Nancy_Nix@URMC.Rochester.edu
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
  • New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
    Contact Information:
        Gherson, Ingrid
        Phone: (914) 594-2348
        Email: ingrid_gherson@nymc.edu
OH
  • Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
    Contact Information:
        Ouellette, Deborah
        Phone: (330) 543-3089
        Email: douellette@chmca.org
PA
  • St. Christopher's Hospital for Children (Pediatric), Philadelphia, PA, 19134
    Contact Information:
        Fritsch, Jacqueline
        Phone: (215) 427-3816
        Email: jacqueline.fritsch@drexelmed.edu
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
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