- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869153
Monitoring Growth of Preterm Infants
September 18, 2018 updated by: University of California, Davis
Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow.
The investigators will examine the use of a computer program to try and identify periods of growth slowing in preterm babies, and compare those results to the usual assessments made on patient care rounds.
Study Overview
Status
Terminated
Conditions
Detailed Description
We wish to examine the use of a mathematical modeling system to see if it can detect poor growth better (and more quickly) than we can clinically.
To do this, we need to know what the clinical team think about a baby's growth day-to-day.
However, after rounds the fellow or NNP with fill in a sheet to say what the team thought about the baby's growth (was it okay, too slow, too fast etc.), and whether any changes were made to improve the baby's growth (e.g.
increased feed volume, change in composition of feeds etc.).
After the baby is discharged home, weight data from the EMR will be entered into the program to try and identify times where growth slowed (or where growth was faster than expected).
We will compare the results of the computer program and the record of the clinical teams thoughts on the ward round, to see if the computer program identified growth slowing more quickly than the clinical team did.
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- NICU, University of California, Davis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Preterm infants of gestational age < 32w at birth, or <1750 weight at birth.
Description
Inclusion Criteria:
Birth weight < 1750g gestational age < 32w at birth
Exclusion Criteria:
- Currently receiving parenteral nutrition or intravenous lipids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Preterm infants
Preterm infants born at either <32 weeks gestation or < 1750g birth weight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of growth slowing
Time Frame: Between birth and hospital discharge, an average of 10weeks
|
At time of hospital discharge retrospectively collected data on daily weights (from the EMR) will be entered in to a computer program, to identify times where weight gain slowed significantly.
This will be compared to the clinical assessment of the baby's growth made at the time (and recorded prospectively)
|
Between birth and hospital discharge, an average of 10weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian Griffin, MD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
June 22, 2015
Study Completion (Actual)
July 10, 2018
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 5, 2013
Study Record Updates
Last Update Posted (Actual)
September 20, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 308519
- UCD-308519 (Other Identifier: UCDavis)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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