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NCT01424696 · ClinicalTrials.gov registry record
Baby Observational and Nutritional Study
A clinical trial, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- 231
- Enrollment target
NCT01424696: Completed study, sponsored by Seattle Children's Hospital.
NCT01424696 is a clinical trial that has completed, run by Seattle Children's Hospital. The registered enrollment target is 231 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01424696 has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- 231 participants
- Enrollment target
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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-04 |
What the finished NCT01424696 record still lists
NCT01424696 is an observational study that tracks outcomes without assigning an intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01424696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01424696 about?
NCT01424696 is a clinical study titled "Baby Observational and Nutritional Study". 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 yea...
What is the current status of trial NCT01424696?
This trial is currently completed. The enrollment target is 231 participants. The study started on 2011-12. Estimated completion is 2015-04.
Who is sponsoring clinical trial NCT01424696?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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