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

NCT ID: NCT04190147

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-28

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Birth Visual Impairment Eye Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-late preterm group

Structural, functional and metabolic eye examinations

Intervention Type OTHER

Structural, functional and metabolic eye examinations

Full-term group

Structural, functional and metabolic eye examinations

Intervention Type OTHER

Structural, functional and metabolic eye examinations

Interventions

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Structural, functional and metabolic eye examinations

Structural, functional and metabolic eye examinations

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of neuroscience and physiology

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MLP15

Identifier Type: -

Identifier Source: org_study_id

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