Baby Observational and Nutritional Study
BONUS
2 other identifiers
observational
231
1 country
28
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedSeptember 28, 2015
September 1, 2015
3.3 years
August 25, 2011
September 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incremental gain in weight, length, and head circumference
To define and describe incremental weight gain and linear growth in the first year of life utilizing research quality growth measures that will be applicable as efficacy outcomes for future interventional studies in infants with CF
one year
Study Arms (1)
Cystic Fibrosis in 1st 3 months of life
Early Diagnosis: Children diagnosed with CF in first 3 months of life
Eligibility Criteria
Infants diagnosed with CF who attend regular clinic visits during the first year of life
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Emory CF Center
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Iowa City University of Iowa
Iowa City, Iowa, 52242, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Helen DeVos Children's Hospital CF Care Center
Grand Rapids, Michigan, 49503, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
State University of New York at Buffalo
Buffalo, New York, 14222, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt CF Center
Nashville, Tennessee, 37232, United States
Austin Children's Chest Associates
Austin, Texas, 78723, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (5)
Sathe M, Huang R, Heltshe S, Eng A, Borenstein E, Miller SI, Hoffman L, Gelfond D, Leung DH, Borowitz D, Ramsey B, Freeman AJ. Gastrointestinal Factors Associated With Hospitalization in Infants With Cystic Fibrosis: Results From the Baby Observational and Nutrition Study. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):395-402. doi: 10.1097/MPG.0000000000003173.
PMID: 34016873DERIVEDGoetz D, Kopp BT, Salvator A, Moore-Clingenpeel M, McCoy K, Leung DH, Kloster M, Ramsey BR, Heltshe SH, Borowitz D. Pulmonary findings in infants with cystic fibrosis during the first year of life: Results from the Baby Observational and Nutrition Study (BONUS) cohort study. Pediatr Pulmonol. 2019 May;54(5):581-586. doi: 10.1002/ppul.24261. Epub 2019 Jan 22.
PMID: 30672141DERIVEDLeGrys VA, Moon TC, Laux J, Accurso F, Martiniano SA. A multicenter evaluation of sweat chloride concentration and variation in infants with cystic fibrosis. J Cyst Fibros. 2019 Mar;18(2):190-193. doi: 10.1016/j.jcf.2018.12.006. Epub 2018 Dec 21.
PMID: 30583934DERIVEDKopp BT, Joseloff E, Goetz D, Ingram B, Heltshe SL, Leung DH, Ramsey BW, McCoy K, Borowitz D. Urinary metabolomics reveals unique metabolic signatures in infants with cystic fibrosis. J Cyst Fibros. 2019 Jul;18(4):507-515. doi: 10.1016/j.jcf.2018.10.016. Epub 2018 Nov 23.
PMID: 30477895DERIVEDGelfond D, Heltshe SL, Skalland M, Heubi JE, Kloster M, Leung DH, Ramsey BW, Borowitz D; BONUS Study Investigators. Pancreatic Enzyme Replacement Therapy Use in Infants With Cystic Fibrosis Diagnosed by Newborn Screening. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):657-663. doi: 10.1097/MPG.0000000000001829.
PMID: 29176494DERIVED
Biospecimen
* serum and/or plasma * urine * stool * oropharyngeal swab (OP swab) * saliva * sweat * buccal brushings
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Drucy Borowitz, MD
State University of New York at Buffalo
- PRINCIPAL INVESTIGATOR
Daniel Leung, MD
Baylor College of Medicine
- PRINCIPAL INVESTIGATOR
James Heubi, MD
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Daniel Gelfond, MD
Women & Children's Hospital of Buffalo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2011
First Posted
August 29, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
September 28, 2015
Record last verified: 2015-09