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Baby Observational and Nutritional Study

NCT01424696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2015-09-28

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Drucy Borowitz, MD · State University of New York at Buffalo

  • Daniel Leung, MD · Baylor College of Medicine

  • James Heubi, MD · University of Cincinnati

  • Daniel Gelfond, MD · Women & Children's Hospital of Buffalo

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424696 on ClinicalTrials.gov