Baby Observational and Nutritional Study

Completed

Conditions studied: Cystic Fibrosis, Growth Failure, Exocrine Pancreatic Insufficiency

In brief

Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth. Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of infants. Two different doses of PERT will be evaluated for improving fat and nitrogen absorption in infants with CF.

Key facts

Study ID

NCT01424696

Run by

Seattle Children's Hospital

People needed

231

Starts

2011-12-01

Expected to finish

2015-04-01

Last updated by the study team

2015-09-28

Who can join

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

You may qualify if…

• Signed informed consent
• Males or females no more than three and one half (3.5) months of age at enrollment
• Documentation of a CF diagnosis as evidenced by:
• One or more of the following: one or more clinical features consistent with the CF phenotype OR a positive newborn screening (NBS) OR a positive pre-natal screen
• AND
• One or more of the following: sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT) OR two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Enrolled in the Cystic Fibrosis Foundation Patient Registry. (Patients may enroll in the Registry at Enrollment Visit if not previously enrolled.)

You may not qualify if…

• Children unable to take full oral feeds
• Any serious or active medical condition, which in the opinion of the investigator, contributes to malabsorption, interferes with normal growth, or would otherwise interfere with subject's treatment, assessment, or compliance with the protocol.
• Gestational age less than 35 weeks and/or birth weight < 2.5 kg.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Emory CF Center — Atlanta, Georgia, United States
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Iowa City University of Iowa — Iowa City, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Helen DeVos Children's Hospital CF Care Center — Grand Rapids, Michigan, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• State University of New York at Buffalo — Buffalo, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt CF Center — Nashville, Tennessee, United States
• Austin Children's Chest Associates — Austin, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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