Eye and Growth in Adolescents Born Moderate-to-late Preterm
- Conditions
- Eye AbnormalitiesPreterm BirthVisual Impairment
- Interventions
- Other: Structural, functional and metabolic eye examinations
- Registration Number
- NCT04190147
- Lead Sponsor
- Vastra Gotaland Region
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Born moderate-to-late preterm.
- Born in Gothenburg, Sweden.
- Born between years 2002 and 2004.
- Chromosomal abnormalities.
- Syndromes.
- Severe malformations.
- Asphyxia.
- Language difficulties.
- Psychosocial problems at birth.
- Severe maternal illness.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Moderate-to-late preterm group Structural, functional and metabolic eye examinations - Full-term group Structural, functional and metabolic eye examinations -
- Primary Outcome Measures
Name Time Method Optic disc area. Through study completion, an average of 6 months Optic disc area measured with Optical coherence tomography (OCT, Topcon).
Visual acuity. Through study completion, an average of 6 months. Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.
Refraction. Through study completion, an average of 6 months. Visual refraction measured with an autorefractor (Topcon).
Blood concentration of Hemoglobin A1c (HbA1c). Through study completion, an average of 6 months. Blood samples of HbA1c.
Autism Spectrum Screening Questionnaire (ASSQ). Through study completion, an average of 6 months. 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).
Height. Through study completion, an average of 6 months. Height measured in meters.
Blood pressure. Through study completion, an average of 6 months. Systolic and diastolic blood pressure measured with blood pressure cuffs.
Pediatric Quality of Life Inventory (PedsQL). Through study completion, an average of 6 months. 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).
Weight. Through study completion, an average of 6 months Weight measured in kilograms.
The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV). Through study completion, an average of 6 months. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of neuroscience and physiology
🇸🇪Gothenburg, Vastra Gotaland, Sweden