Gestational AgeNCT02346214
Smartphone Ophthalmoscope of Lens Vascularity to Estimate Gestational Age
An observational study of Gestational Age, run by RTI International at 3 sites in United States.
Trial summary
The purpose of this study is to develop a novel, highly automated method of gestational age estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical parameters appropriate for use in low income countries. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Gestational Age
- How many people
- 252 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 30 Nov 2017
- 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 Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Singleton live births between 26 and 42 weeks' gestation (determined by first or early-second trimester ultrasound dating)
Who may be able to join
- Gestational age 260/7 to 426/7 weeks (based on antenatal ultrasound <20 weeks gestation)
- Chronological age <24 hours
- Consent of the patient's parents or legal guardians
Who cannot join
- Fused eyelids
- Corneal opacity or cataract
- Obstetrical ultrasound performed at <20 weeks' gestation not performed/not available
- Known genetic/congenital anomalies
- Known coagulopathies
- Patients who, in the opinion of the attending physician or clinical study staff, are too medically unstable to participate in the study safely
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina at Chapel Hill North Carolina Children's Hospital
Chapel Hill, North Carolina, 27599-2200
University of Iowa Children's Hospital
Iowa City, Iowa, 45542
Loma Linda University Children's Hospital
Loma Linda, California, 92345
About this study
Official title: Smartphone Ophthalmoscope Lens Vascularity Estimated Gestational Age (SOLVE-GA)
The purpose of this study is to develop a novel, highly automated method of gestational age estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical parameters appropriate for use in low income countries. The specific aims of the proposed study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize that the accuracy of the predictive algorithm will be comparable to commonly used measures of gestational age dating (±2 days) and have better precision (±14 days) than commonly used measures of gestational age dating.
Read the detailed description
Postnatal gestational age dating methods are needed in low/middle income settings as ultrasound is often unavailable, last menstrual dates uncertain, and physical/neurological scoring complex. The disappearance of anterior lens capsule vascularity (ALCV), a normal embryological process, has a high correlation with gestational age at delivery among preterm neonates. We will use an observational method-comparison study to establish the validity of smartphone ophthalmoscope ALCV gestational age estimates among preterm infants at delivery compared to the referent standard of ultrasound gestational age estimates. Study objectives and methods include the following: Objective 1. Develop an ALCV biomarker dataset from smartphone ophthalmoscope images using automated image analysis software. The dataset will include image features including: vessel quantity, lens clearing, tortuosity, vessel thickness, and branching angles and coefficients. Methods: (1) capture ALCV images via smartphone ophthalmoscope within 24 hours of delivery, and (2) segment ALCV images using software developed for the assessment of retinal vasculature. Proposed software will convert images into graphs and automatically find the vasculature based on the Dijkstra's shortest-path algorithm. The proposed software is tested for video-indirect neonatal ophthalmoscope images. Objective 2. Develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with the ALCV biomarker dataset combined with key neonatal biophysical measures. Methods: (1) conduct descriptive and univariate analyses of predictors and assess linear model assumptions, and (2) fit a constrained linear regression model by selecting and shrinking estimated model coefficients from a fully specified model in the original sample to optimize predictive accuracy and model parsimony. Objective 3. Assess the performance of ALCV gestational age estimates compared to referent standard ultrasound estimates. Methods: (1) compare distributions of gestational age and the mean difference in days between dating methods, (2) test agreement between dating methods using Lin's concordance correlation coefficient and Bland-Altman plots with limits of agreement (3) internally validate test agreement using a bootstrap procedure for optimism correction of the agreement statistics. All statistical analyses will be performed in SAS 9.4 (SAS, Cary, North Carolina, USA).
- Conditions
- Gestational Age
- Keywords
- Gestational Age, Anterior Lens Capsule Vascularity, Preterm, Method-comparison
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm and term neonates | A. Preterm and term neonates B. Singleton live births between 26 and 42 weeks gestation (determined by first of early-second trimester ultrasound dating) at three referral hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior lens capsule vascularity estimated gestational age
The gestational age is estimated by eye lens vascularity measurement
Measured: Within 24 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJul 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gestational AgeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Duke University, Loma Linda University, University of Iowa
- Responsible party
- Sponsor
- Investigators
- Jennifer Griffin, Ph.D. M.P.H., Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346214
- Sponsor's protocol ID
- OPP1119360
- Status last verified
- Jan 2018
- First submitted
- 20 Jan 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Altman, D. G. and J. M. Bland (1983).
Bland, J. M. and D. G. Altman (2010).
Blencowe, H., S. Cousens, D. Chou, M. Oestergaard, L. Say, A.-B. Moller, M. Kinney and J. Lawn (2013).
Concato, J., P. Peduzzi, T. R. Holford and A. R. Feinstein (1995). Estrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2011).
Estrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2012).
Hittner HM, Gorman WA, Rudolph AJ. Examination of the anterior vascular capsule of the lens: II. Assessment of gestational age in infants small for gestational age. J Pediatr Ophthalmol Strabismus. 1981 Mar-Apr;18(2):52-4. doi: 10.3928/0191-3913-19810301-12.
PubMed 7195426Hittner HM, Hirsch NJ, Rudolph AJ. Assessment of gestational age by examination of the anterior vascular capsule of the lens. J Pediatr. 1977 Sep;91(3):455-8. doi: 10.1016/s0022-3476(77)81324-3.
PubMed 894419Nagpal J, Kumar A, Ramji S. Anterior lens capsule vascularity in evaluating gestation in small for gestation neonates. Indian Pediatr. 2004 Aug;41(8):817-21.
PubMed 15347869
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Ophthalmoscope Lens Vascularity Estimated Gestational Age (SOLVE-GA)
- ClinicalTrials.gov ID
- NCT02346214
- Acronym / sponsor ID
- OPP1119360
- Conditions
- Gestational Age
- Keywords
- Gestational Age, Anterior Lens Capsule Vascularity, Preterm, Method-comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Duke University, Loma Linda University, University of Iowa
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 26 Jan 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.
The purpose of this study is to develop a novel, highly automated method of gestational age estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical parameters appropriate for use in low income countries. The specific aims of the proposed study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize that the accuracy of the predictive algorithm will be comparable to commonly used measures of gestational age dating (±2 days) and have better precision (±14 days) than commonly used measures of gestational age dating.
Detailed description
Postnatal gestational age dating methods are needed in low/middle income settings as ultrasound is often unavailable, last menstrual dates uncertain, and physical/neurological scoring complex. The disappearance of anterior lens capsule vascularity (ALCV), a normal embryological process, has a high correlation with gestational age at delivery among preterm neonates. We will use an observational method-comparison study to establish the validity of smartphone ophthalmoscope ALCV gestational age estimates among preterm infants at delivery compared to the referent standard of ultrasound gestational age estimates. Study objectives and methods include the following: Objective 1. Develop an ALCV biomarker dataset from smartphone ophthalmoscope images using automated image analysis software. The dataset will include image features including: vessel quantity, lens clearing, tortuosity, vessel thickness, and branching angles and coefficients. Methods: (1) capture ALCV images via smartphone ophthalmoscope within 24 hours of delivery, and (2) segment ALCV images using software developed for the assessment of retinal vasculature. Proposed software will convert images into graphs and automatically find the vasculature based on the Dijkstra's shortest-path algorithm. The proposed software is tested for video-indirect neonatal ophthalmoscope images. Objective 2. Develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with the ALCV biomarker dataset combined with key neonatal biophysical measures. Methods: (1) conduct descriptive and univariate analyses of predictors and assess linear model assumptions, and (2) fit a constrained linear regression model by selecting and shrinking estimated model coefficients from a fully specified model in the original sample to optimize predictive accuracy and model parsimony. Objective 3. Assess the performance of ALCV gestational age estimates compared to referent standard ultrasound estimates. Methods: (1) compare distributions of gestational age and the mean difference in days between dating methods, (2) test agreement between dating methods using Lin's concordance correlation coefficient and Bland-Altman plots with limits of agreement (3) internally validate test agreement using a bootstrap procedure for optimism correction of the agreement statistics. All statistical analyses will be performed in SAS 9.4 (SAS, Cary, North Carolina, USA).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm and term neonates | – | –A. Preterm and term neonates B. Singleton live births between 26 and 42 weeks gestation (determined by first of early-second trimester ultrasound dating) at three referral hospitals |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Singleton live births between 26 and 42 weeks' gestation (determined by first or early-second trimester ultrasound dating)
Key inclusion criteria (3 listed)
- Gestational age 260/7 to 426/7 weeks (based on antenatal ultrasound <20 weeks gestation)
Key exclusion criteria (6 listed)
- Fused eyelids
- Corneal opacity or cataract
- Obstetrical ultrasound performed at <20 weeks' gestation not performed/not available
- Known genetic/congenital anomalies
- Known coagulopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anterior lens capsule vascularity estimated gestational age
Time frame: Within 24 hours of delivery
The gestational age is estimated by eye lens vascularity measurement
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 17 Jan 2018.
- BackgroundAltman, D. G. and J. M. Bland (1983).
- BackgroundBland, J. M. and D. G. Altman (2010).
- BackgroundBlencowe, H., S. Cousens, D. Chou, M. Oestergaard, L. Say, A.-B. Moller, M. Kinney and J. Lawn (2013).
- BackgroundConcato, J., P. Peduzzi, T. R. Holford and A. R. Feinstein (1995). Estrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2011).
- BackgroundEstrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2012).
- Background: PubMed 7195426Hittner HM, Gorman WA, Rudolph AJ. Examination of the anterior vascular capsule of the lens: II. Assessment of gestational age in infants small for gestational age. J Pediatr Ophthalmol Strabismus. 1981 Mar-Apr;18(2):52-4. doi: 10.3928/0191-3913-19810301-12.
- Background: PubMed 894419Hittner HM, Hirsch NJ, Rudolph AJ. Assessment of gestational age by examination of the anterior vascular capsule of the lens. J Pediatr. 1977 Sep;91(3):455-8. doi: 10.1016/s0022-3476(77)81324-3.
- Background: PubMed 15347869Nagpal J, Kumar A, Ramji S. Anterior lens capsule vascularity in evaluating gestation in small for gestation neonates. Indian Pediatr. 2004 Aug;41(8):817-21.
- Individual participant dataSharing planned: No
Related trials for Gestational Age
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
Jennifer Griffin, Ph.D. M.P.H. principal investigator
RTI International
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age, run by RTI International at 3 sites 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 3 inclusion and 6 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Anterior lens capsule vascularity estimated gestational age (time frame: Within 24 hours of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346214, which also lists 8 linked publications.
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 17 Jan 2018.