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Smartphone Ophthalmoscope of Lens Vascularity to Estimate Gestational Age

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ClinicalTrials.gov Identifier: NCT02346214
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Duke University
Loma Linda University
University of Iowa
Information provided by (Responsible Party):
RTI International

Brief 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. 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.

Condition or disease
Gestational Age

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 Type : Observational
Actual Enrollment : 252 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Smartphone Ophthalmoscope Lens Vascularity Estimated Gestational Age (SOLVE-GA)
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Group/Cohort
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



Primary Outcome Measures :
  1. Anterior lens capsule vascularity estimated gestational age [ Time Frame: Within 24 hours of delivery ]
    The gestational age is estimated by eye lens vascularity measurement



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Singleton live births between 26 and 42 weeks' gestation (determined by first or early-second trimester ultrasound dating)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346214


Locations
United States, California
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92345
United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 45542
United States, North Carolina
University of North Carolina at Chapel Hill North Carolina Children's Hospital
Chapel Hill, North Carolina, United States, 27599-2200
Sponsors and Collaborators
RTI International
University of North Carolina, Chapel Hill
Duke University
Loma Linda University
University of Iowa
Investigators
Principal Investigator: Jennifer Griffin, Ph.D. M.P.H. RTI International

Publications:
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT02346214     History of Changes
Other Study ID Numbers: OPP1119360
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RTI International:
Gestational Age
Anterior Lens Capsule Vascularity
Preterm
Method-comparison