Status:
COMPLETED
Baby Observational and Nutritional Study
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Cystic Fibrosis Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystic Fibrosis
Growth Failure
Eligibility:
All Genders
Up to 3 years
Brief Summary
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 gro...
Detailed Description
Newborn screening (NBS) for cystic fibrosis (CF) has decreased the prevalence of malnutrition in infancy, but suboptimal nutrition still persists. In one study, 60% of infants diagnosed by NBS achieve...
Eligibility Criteria
Inclusion
- Observational Study
- 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.)
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01424696
Start Date
December 1 2011
End Date
April 1 2015
Last Update
September 28 2015
Active Locations (28)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Emory CF Center
Atlanta, Georgia, United States, 30322