Use of Formula Fortified With DHA in Infants With Cystic Fibrosis

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

The hypothesis of this study is that feeding infants diagnosed with CF via newborn screening a formula enhanced with a specific fish-oil fatty acid known as DHA will improve growth and decrease pancreatic dysfunction (as measured by human fecal elastase-1 in stool) over the first year of life. Briefly, infants diagnosed with CF in the first month of life whose parents chose not to breast feed their babies will be invited to enroll in a study comparing a standard commercial infant formula (Enfamil) with a formula enriched with arachidonic acid (AA) and docosahexaenoic acid (DHA). The study formula has 3 times the amount of DHA available in commercially available formulas. Infants will have monthly tests of stool elastase and blood work at entry, 3, 6, 9 and 12 months of age.

Key facts

Study ID

NCT00530244

Run by

University of Massachusetts, Worcester

People needed

76

Starts

2003-03-01

Expected to finish

2011-10-01

Last updated by the study team

2018-03-07

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant diagnosed with CF and enrolled by 56 days of life
• Parental consent obtained

You may not qualify if…

• History of meconium ileus at birth that is resolved without surgical intervention (ie enema)
• History of bowel resection for any reason
• Breast feeding
• Premature birth (<34 weeks gestation)
• Severe cholestasis (Direct Bilirubin > 2x upper limit of normal for age)
• Severe hypoalbuminemia (Albumin < 2.5 gm/dl)

Where it is running

• UAB/CHS Cystic Fibrosis Center — Birmingham, Alabama, United States
• Emory Cystic Fibrosis Center — Atlanta, Georgia, United States
• Blank Children's Hospital — Des Moines, Iowa, United States
• Cystic Fibrosis Care & Teaching Center — Wichita, Kansas, United States
• Kosair Charities — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• UMass Memorial Healthcare — Worcester, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Monmouth Medical Center — Long Branch, New Jersey, United States
• The Respiratory Center for Children — Morristown, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Children's Hospital — Buffalo, New York, United States
• Schneider Children's Hospital — New Hyde Park, New York, United States
• Strong Memorial Hospital — Rochester, New York, United States
• Univesity Medical Center — Stony Brook, New York, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• Children's Hospital at Westchester Medical Center — Valhalla, New York, United States
• Lewis H Walker CF Pulmonary Center — Akron, Ohio, United States
• Lewis H Walker Cystic Fibrosis Center Division of Pulmonary — Akron, Ohio, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Mountain State University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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