Clinical trial NCT04190147: Eye and Growth in Adolescents Born Moderate-to-late Preterm
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Visual Impairment
Eye Abnormalities
Keywords: Moderate-to-late preterm
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Optic disc area.
timeFrame: Through study completion, an average of 6 months
measure: Visual acuity.
timeFrame: Through study completion, an average of 6 months.
measure: Blood pressure.
timeFrame: Through study completion, an average of 6 months.
measure: Blood concentration of Hemoglobin A1c (HbA1c).
timeFrame: Through study completion, an average of 6 months.
measure: Autism Spectrum Screening Questionnaire (ASSQ).
timeFrame: Through study completion, an average of 6 months.
measure: Pediatric Quality of Life Inventory (PedsQL).
timeFrame: Through study completion, an average of 6 months.
measure: Weight.
timeFrame: Through study completion, an average of 6 months
measure: The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV).
timeFrame: Through study completion, an average of 6 months.
measure: Refraction.
timeFrame: Through study completion, an average of 6 months.
measure: Height.
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Institute of neuroscience and physiology
state: Vastra Gotaland
Study officials:
References: