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Growth RetardationNCT02403739

Visual Interpretation of Neonatal Growth Charts

An observational study of Growth Retardation and Growth Acceleration, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Growth Retardation, Growth Acceleration
How many people
50 participants
Where
1 siteUnited States
Study dates
Mar 2015to May 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC Davis

    Sacramento, California, 95817

Other trials in United States

About this study

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.

Read the detailed description

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)
Being tested
No Intervention
Keywords
Growth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correct answers

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403739
Sponsor's protocol ID
686881
Other IDs
Z001
Status last verified
Jun 2017
First submitted
19 Mar 2015
Last updated
21 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Retardation and Growth Acceleration, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct answers (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.

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