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

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

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.

Study Overview

• Status: Completed
• Conditions: Eye Abnormalities; Preterm Birth; Visual Impairment
• Intervention / Treatment: Other: Structural, functional and metabolic eye examinations

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Sweden
  • Vastra Gotaland
    • Gothenburg, Vastra Gotaland, Sweden, SE-413 45
      • Institute of Neuroscience and Physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate-to-late preterm group	Other: Structural, functional and metabolic eye examinations; Structural, functional and metabolic eye examinations
Full-term group	Other: Structural, functional and metabolic eye examinations; Structural, functional and metabolic eye examinations

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2019
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Moderate-to-late preterm
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Congenital Abnormalities; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Sensation Disorders; Premature Birth; Vision, Low; Vision Disorders; Eye Abnormalities
• Other Study ID Numbers: MLP15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No