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

Preterm Birth Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190147
• Other study ID #: MLP15
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2021
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Abnormalities
• Premature Birth
• Preterm Birth
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Structural, functional and metabolic eye examinations
Structural, functional and metabolic eye examinations

Locations

Country	Name	City	State
Sweden	Institute of neuroscience and physiology	Gothenburg	Vastra Gotaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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