Eye and Growth in Adolescents Born Moderate-to-late Preterm

Study Overview
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Brief Summary
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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.

Official Title
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Ocular Morphology and Visual Function in Relation to Growth, Metabolic, Cardiovascular, and Neuropsychiatric Status, and Quality of Life in Adolescents Born Moderate-to-late Preterm

Conditions
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Preterm Birth, Visual Impairment, Eye Abnormalities

Intervention / Treatment
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* Other: Structural, functional and metabolic eye examinations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born moderate-to-late preterm. Born in Gothenburg, Sweden. Born between years 2002 and 2004. Exclusion Criteria: Chromosomal abnormalities. Syndromes. Severe malformations. Asphyxia. Language difficulties. Psychosocial problems at birth. Severe maternal illness.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate-to-late preterm group<br> | Other: Structural, functional and metabolic eye examinations<br>* Structural, functional and metabolic eye examinations<br>|
| Full-term group<br> | Other: Structural, functional and metabolic eye examinations<br>* Structural, functional and metabolic eye examinations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic disc area. | Optic disc area measured with Optical coherence tomography (OCT, Topcon). | Through study completion, an average of 6 months | 
| Visual acuity. | Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores. | Through study completion, an average of 6 months. | 
| Blood pressure. | Systolic and diastolic blood pressure measured with blood pressure cuffs. | Through study completion, an average of 6 months. | 
| Blood concentration of Hemoglobin A1c (HbA1c). | Blood samples of HbA1c. | 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). | 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). | Through study completion, an average of 6 months. | 
| Weight. | Weight measured in kilograms. | 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). | Through study completion, an average of 6 months. | 
| Refraction. | Visual refraction measured with an autorefractor (Topcon). | Through study completion, an average of 6 months. | 
| Height. | Height measured in meters. | Through study completion, an average of 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate-to-late preterm