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.
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.
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)
- Conditions
- Growth Retardation, Growth Acceleration
- 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.
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.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth RetardationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Interpretation of Neonatal Growth Charts: A Comparison of Z-score Charts and Traditional Charts
- ClinicalTrials.gov ID
- NCT02403739
- Acronym / sponsor ID
- 686881
- Conditions
- Growth Retardation, Growth Acceleration
- Keywords
- Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | – |
Primary outcome
Correct answers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.