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

• Sponsor: Vastra Gotaland Region (Other)
• Overall Status: Completed
• CT.gov ID: NCT04190147
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth; Visual Impairment; Eye Abnormalities	Other: Structural, functional and metabolic eye examinations

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 28, 2019
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Optic disc area. [Through study completion, an average of 6 months]

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

2. Visual acuity. [Through study completion, an average of 6 months.]

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

3. Blood pressure. [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). [Through study completion, an average of 6 months.]

   Blood samples of HbA1c.

5. Autism Spectrum Screening Questionnaire (ASSQ). [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). [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. [Through study completion, an average of 6 months]

   Weight measured in kilograms.

8. The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV). [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. [Through study completion, an average of 6 months.]

   Visual refraction measured with an autorefractor (Topcon).

10. Height. [Through study completion, an average of 6 months.]

    Height measured in meters.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of neuroscience and physiology	Gothenburg	Vastra Gotaland	Sweden	SE-413 45

Sponsors and Collaborators

• Vastra Gotaland Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vastra Gotaland Region
• ClinicalTrials.gov Identifier: NCT04190147
• Other Study ID Numbers: MLP15
• First Posted: Dec 9, 2019
• Last Update Posted: May 6, 2022
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vastra Gotaland Region: Moderate-to-late preterm
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Eye Abnormalities; Premature Birth

Study Results

No Results Posted as of May 6, 2022