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Therapeutic Areas: Pulmonary/Respiratory Diseases
Disease Category: Cystic Fibrosis

Trial Information

Use of Formula Fortified With DHA in Infants With Cystic Fibrosis

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.

Patient Inclusion Criteria:

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

Patient Exclusion Criteria:

• 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)

Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown, NJ 07962
Phone: 973-660-3139
EMail: kelly.colucci@atlantichealth.org

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