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NCT Number: NCT04190147

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

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.

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Key information

Conditions

Preterm Birth Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sensation Disorders Signs and Symptoms Urogenital Diseases Vision Disorders Visual Impairment

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of neuroscience and physiology

Gothenburg, Västra Götaland County, SE-413 45, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structural, functional and metabolic eye examinations

Other

Structural, functional and metabolic eye examinations

Primary outcomes

  1. Optic disc area.

    Time frame: Through study completion, an average of 6 months

    Optic disc area measured with Optical coherence tomography (OCT, Topcon).

  2. Visual acuity.

    Time frame: Through study completion, an average of 6 months.

    Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.

  3. Blood pressure.

    Time frame: Through study completion, an average of 6 months.

    Systolic and diastolic blood pressure measured with blood pressure cuffs.

  4. Blood concentration of Hemoglobin A1c (HbA1c).

    Time frame: Through study completion, an average of 6 months.

    Blood samples of HbA1c.

  5. Autism Spectrum Screening Questionnaire (ASSQ).

    Time frame: 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).

  6. Pediatric Quality of Life Inventory (PedsQL).

    Time frame: 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).

  7. Weight.

    Time frame: Through study completion, an average of 6 months

    Weight measured in kilograms.

  8. The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV).

    Time frame: 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).

  9. Refraction.

    Time frame: Through study completion, an average of 6 months.

    Visual refraction measured with an autorefractor (Topcon).

  10. Height.

    Time frame: Through study completion, an average of 6 months.

    Height measured in meters.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2019
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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