Growth Retardation Clinical Trial
Official title:
Visual Interpretation of Neonatal Growth Charts: A Comparison of Z-score Charts and Traditional Charts
Simulated growth data will be shown to clinicians in two formats - (1) as weight vs.age charts, (2) as weight Z-score vs. age charts. Clinicians will be asked to identify whether growth is too fast, too slow, or normal. The test will take a total of 10 minutes.
BACKGROUND Optimization of growth is essential for preterm infants. Optimum post-natal
growth has been shown to improve long-term developmental outcomes. Close monitoring of
weight gain, including early identification of growth faltering, is an important part of
appropriate nutritional management in the Neonatal Intensive Care Unit.
Current practices in neonatal intensive care units involve the routine use of growth charts
to track and identify patterns in the growth of preterm infants. Perhaps the most popular
growth chart in use today is the Fenton Growth Chart. To interpret this chart, a patient's
growth curve is plotted over a set of standard curves (typically representing the 10th,
25th, 50th, 75th and 90th weight-for-age centile). The curves are then visually compared to
identify patterns in growth (adequate, slow, or catch-up growth). Patterns in neonatal
growth may be subtle and current growth curves may be prone to misinterpretation. This may
be due to biases inherent in the human visual perception system, including the difficulty in
visually estimating slopes and angles between two curves.
An improved growth chart would use horizontal lines rather than curves, and would have no
oblique lines to skew visual perception. Z-score growth charts accomplish this. Z-score
growth charts are created using the same standardized data used to create the Fenton Growth
Chart. Z-scores represent standard deviation scores. Rather than using a set of standard
curves to represent average healthy growth, the z-score chart uses a single horizontal line.
This allows for easier comparison when plotting a patient's weights over time. Such charts
may lead to more accurate interpretation of overall growth patterns.
This study will compares the accuracy of interpretation of the growth data using the same
standard - once as presented using traditional weight-vs.-age charts, and again using the
same data displayed as Z-score vs age charts.
INCLUSION AND EXCLUSION CRITERIA
It will include UC Davis Medical Center healthcare personnel who interpret growth charts for
preterm infants. This may include the following:
- Attending Neonatologists
- Attending Pediatricians
- Dietitians
- Medical Students
- Neonatal Fellows
- Neonatal Nurse Practitioners
- Pediatric Residents This study will exclude persons who do not routinely interpret
growth charts for preterm infants as part of their clinical responsibilities.
NUMBER OF SUBJECTS This will be a single center study. The sample size needed for 80% power
with an alpha of 0.05 is estimated to be at least 40. Approaching 45-50 providers should be
sufficient to achieve this number.
RECRUITMENT METHODS Healthcare providers who meet the inclusion criteria will be approached
on an individual and/or group basis. We may attempt to hold a meeting (perhaps at lunch
time) when volunteers may participate in the study.
COMPENSATION TO SUBJECTS If there is a meeting held at lunchtime for volunteers to
participate in this study, there may be a small lunch provided (such as sandwiches, pizza
and/or soft drinks). When subjects are approached on an individual basis, there will be no
compensation offered.
STUDY TIMELINES
- The duration of an individual subject's participation in the study: less than one hour.
- The duration anticipated to enroll all study subjects: three to six months.
- The estimated date for the investigators to complete this study (complete primary
analyses): Less than six months
STUDY ENDPOINTS Primary endpoint: after 40-50 persons have completed the study. Primary or
secondary safety endpoints: there are no foreseeable safety issues with participating in
this questionnaire based study.
PROCEDURES INVOLVED
Study design:
- Study subjects will be asked to view a brief presentation. This will describe Fenton
Preterm and Z-score growth charts, and review how they are interpreted.
- Hypothetical (i.e. dummy data) for 10-20 infants will be displayed both as weigh vs.
age charts and as Z-score vs age charts. The data will consist of 2 points
approximately 1-2w apart. Subjects will be asked whether the growth between the two
points is "normal" (paralleling centile lines on the weight vs age charts, or
horizontal on the Z-score vs age charts), "slower than normal" or "faster than
normal"). The order of presentation of the charts will be randomized
- Subjects will record their interpretation of the growth data on a sheet (marking a box
for "normal", "faster than normal" or "slower than normal".
- At the end of the presentation subjects will be asked to record their level of training
(medical student, resident, fellow, NNP, neonatal attending, or other) on the sheet.
- A space will be provided on the datasheet for subjects to record any impression of the
charts they may wish to share.
- Subjects will be provided unmarked envelopes to put their datasheets in to return them
to the investigators (so investigators will be unaware of the answers, or whether the
subjects completed the datasheet)
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