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

NCT04190147 | Completed

• 1 other identifier: MLP15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Visual Impairment; Eye Abnormalities

Keywords

Moderate-to-late preterm

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (2)

Moderate-to-late preterm group

Other: Structural, functional and metabolic eye examinations

Full-term group

Other: Structural, functional and metabolic eye examinations

Interventions

Structural, functional and metabolic eye examinations OTHER

Structural, functional and metabolic eye examinations

Full-term group; Moderate-to-late preterm group

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Born moderate-to-late preterm.
• Born in Gothenburg, Sweden.
• Born between years 2002 and 2004.

You may not qualify if:

• Chromosomal abnormalities.
• Syndromes.
• Severe malformations.
• Asphyxia.
• Language difficulties.
• Psychosocial problems at birth.
• Severe maternal illness.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Institute of neuroscience and physiology

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

Location

MeSH Terms

Conditions

Premature Birth; Vision Disorders; Eye Abnormalities

Interventions

Functional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: December 9, 2019
• Study Start: October 28, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 6, 2022

Record last verified: 2021-01

Locations

SE (1)