An observational study in Preterm Birth, Visual Impairment and Eye Abnormalities, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 15 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Vastra Gotaland Region · Observational
During recent years, the interest in studying the risks of being born moderate-to-late preterm (MLP), defined as birth between gestational week 32 to 36, has increased. Today the investigators know that morbidity and mortality are significantly higher in these individuals compared to individuals born full-term. However, few studies have focused on the development of the eye in MLP individuals. The purpose of the study is to evaluate eye morphology and visual function in relation to growth, metabolism, blood pressure, neuropsychiatric factors, and quality of life in adolescents born MLP. The results of the examinations will be compared to an age-matched control group. The study will evaluate the structural, functional, and metabolic aspects of the eye with the hypothesis that early eye abnormalities may detect the risk of developing metabolic and cardiovascular diseases.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 100 is below the median of 115 across 798 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Vastra Gotaland Region is the lead sponsor of 272 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Year 2002 to 2004, 247 children born moderate-to-late preterm i Gothenburg, Sweden, were enrolled in a prospective, longitudinal and population-based cohort study. These children will be asked to participate in the present follow-up study 15 years later. The age-matched control group born full-term will be recruited from schools in Gothenburg.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Structural, functional and metabolic eye examinations
Other: Structural, functional and metabolic eye examinations
Structural, functional and metabolic eye examinations
Optic disc area.
Optic disc area measured with Optical coherence tomography (OCT, Topcon).
Time frame: Through study completion, an average of 6 months
Visual acuity.
Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.
Time frame: Through study completion, an average of 6 months.
Blood pressure.
Systolic and diastolic blood pressure measured with blood pressure cuffs.
Time frame: Through study completion, an average of 6 months.
Blood concentration of Hemoglobin A1c (HbA1c).
Blood samples of HbA1c.
Time frame: Through study completion, an average of 6 months.
Autism Spectrum Screening Questionnaire (ASSQ).
The ASSQ consists of 27 items and is scored using a likert scale, with the following alternatives: "not true" (0 points), "somewhat true" (1 point) and "certainly true" (2 points).
Time frame: Through study completion, an average of 6 months.
Pediatric Quality of Life Inventory (PedsQL).
PedsQL is a questionnaire measuring health-related quality of life in children and adolescents aged 2 to 18 years. It consists of 23 items including physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). It has a 5-point response scale: "never a problem" (0 points), "almost never a problem" (1 point), "sometimes a problem" (2 points), "often a problem" (3 points), "almost always a problem" (4 points).
Time frame: Through study completion, an average of 6 months.
Weight.
Weight measured in kilograms.
Time frame: Through study completion, an average of 6 months
The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV).
Screening questionnaire for attention deficit hyperactivity disorder (ADHD) consisting of 26 items rated on a 4-point scale: "not at all" (0 points), "just a little" (1 point), "quite a bit" (2 points) and "very much" (3 points).
Time frame: Through study completion, an average of 6 months.
Refraction.
Visual refraction measured with an autorefractor (Topcon).
Time frame: Through study completion, an average of 6 months.
Height.
Height measured in meters.
Time frame: Through study completion, an average of 6 months.
Ran from Oct 2019 to primary completion in Oct 2021, 23 months.
Of 360 non-industry observational studies under Premature Birth, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's 23 months is below that.
Counting every sponsor, half of 377 studies reached it within 32 months; a quarter within 16 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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