|
|
| 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. |
| 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. |
| Sponsor Contact Information: |
O'Sullivan, Brian
(508) 856-4155
OSullivb@ummhc.org
|
| 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) 727-9960
Email: eahunte@emory.edu
|
| KS |
-
Via Christi - Saint Francis Campus (Pediatric), Wichita, KS, 67218
Contact Information:
Miller, Sheri
Phone: (316) 268-6028
Email: Sheri.Miller@viachristi.org
|
| MA |
-
Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
Leone Thakkallapalli, Erin
Phone: (617) 355-3197
Email: erin.leone@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@sbhcs.com
|
| NY |
-
Albany Medical College (Pediatric), Albany, NY, 12208
Contact Information:
Evans, Terese
Phone: (518) 262-5293
Email: evansmt@mail.amc.edu
-
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:
Jenks, Nancy
Phone: (585) 275-8580
Email: nancy_jenks@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) 594-3320
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:
Aramburo, Marcella
Phone: (215) 427-3816
Email: Marcella.aramburo@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
|
|
