Study Stopped
Study expired; PI failed to submit study to IRB for continuing review
Monitoring Growth of Preterm Infants
2 other identifiers
observational
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedSeptember 20, 2018
September 1, 2018
2.1 years
May 27, 2013
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of growth slowing
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
Study Arms (1)
Preterm infants
Preterm infants born at either \<32 weeks gestation or \< 1750g birth weight
Eligibility Criteria
Preterm infants of gestational age \< 32w at birth, or \<1750 weight at birth.
You may qualify if:
- Birth weight \< 1750g gestational age \< 32w at birth
You may not qualify if:
- Currently receiving parenteral nutrition or intravenous lipids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU, University of California, Davis
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Griffin, MD
University of California, Davis
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
June 5, 2013
Study Start
May 1, 2013
Primary Completion
June 22, 2015
Study Completion
July 10, 2018
Last Updated
September 20, 2018
Record last verified: 2018-09