Baby Observational and Nutritional Study (BONUS)

Study ID
STU 062011-121

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Andrew Hebert
214-456-5618
andrew.hebert@childrens.com

Principal Investigator
Preeti Sharma

Summary

This is a prospective, multi-center, observational cohort study to follow incident cases of
CF for up to 12 months in 225 infants. enrollment at this site will be of 6 infants. observational data will be collected from routine
clinical care visits as recommended by the Cystic Fibrosis Foundation (CFF) evidence-Based Guidelines for the
Management of infants with Cystic Fibrosis. Subjects may be enrolled up to three
and one half (3.5) months of age. Subjects will be seen at months one, two, three, four,
five, six, eight, ten and twelve.
The study is designed to minimize study subject and family stress and inconvenience
while ensuring that the study is conducted following international Conference on Harmonisation e6: Good Clinical Practice (GCP) Consolidated Guidance to ensure
subject safety and data integrity. For this reason, the study is structured around the
family's routine clinical care during the first year of life and each visit occurs at the time
of an infant's monthly clinic visits.
Total duration of an individual subject's participation will be up to 12 months. Subjects
will be seen for a total of up to nine (9) visits. The total duration of the study is expected
to be 24 months (12 month recruitment period and 12 month follow up period).

Participant Eligibility

1. Written informed consent obtained from a subject[Single Quote]s parent/legal guardian and ability for a subject to comply with the requirements for the study
2. Males or females no more than three and one half (3.5) months of age at screening (Visit 1)
3. Documentation of a CF diagnosis as evidenced by:
a. 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
b. 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
4. Enrolled in the Cystic Fibrosis Foundation Patient Registry. (Patients may enroll in the Registry at Enrollment Visit if not previously enrolled.)