Preterm BirthNCT04190147
Eye and Growth in Adolescents Born Moderate-to-late Preterm
An observational study of Preterm Birth and Visual Impairment, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Visual Impairment, Eye Abnormalities
- What is being tested?
- Structural, functional and metabolic eye examinations
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2019to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Born moderate-to-late preterm.
- Born in Gothenburg, Sweden.
- Born between years 2002 and 2004.
Who cannot join
- Chromosomal abnormalities.
- Syndromes.
- Severe malformations.
- Asphyxia.
- Language difficulties.
- Psychosocial problems at birth.
- Severe maternal illness.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Institute of neuroscience and physiology
Gothenburg, Västra Götaland County, SE-413 45
About this study
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
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.
- Conditions
- Preterm Birth, Visual Impairment, Eye Abnormalities
- Being tested
- Structural, functional and metabolic eye examinations
- Keywords
- Moderate-to-late preterm
- Medical subject headings
- Premature Birth, Vision Disorders, Eye Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural, functional and metabolic eye examinationsOther
Structural, functional and metabolic eye examinations
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-late preterm group | Not described Receives: Other: Structural, functional and metabolic eye examinations | |
| Full-term group | Not described Receives: Other: Structural, functional and metabolic eye examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic disc area.
Optic disc area measured with Optical coherence tomography (OCT, Topcon).
Measured: Through study completion, an average of 6 months
Visual acuity.
Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.
Measured: Through study completion, an average of 6 months.
Blood pressure.
Systolic and diastolic blood pressure measured with blood pressure cuffs.
Measured: Through study completion, an average of 6 months.
Blood concentration of Hemoglobin A1c (HbA1c).
Blood samples of HbA1c.
Measured: 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).
Measured: 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).
Measured: Through study completion, an average of 6 months.
Weight.
Weight measured in kilograms.
Measured: 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).
Measured: Through study completion, an average of 6 months.
Refraction.
Visual refraction measured with an autorefractor (Topcon).
Measured: Through study completion, an average of 6 months.
Height.
Height measured in meters.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start28 Oct 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190147
- Sponsor's protocol ID
- MLP15
- Status last verified
- Jan 2021
- First submitted
- 22 Aug 2019
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04190147
- Acronym / sponsor ID
- MLP15
- Conditions
- Preterm Birth, Visual Impairment, Eye Abnormalities
- Keywords
- Moderate-to-late preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-late preterm group | – | Other: Structural, functional and metabolic eye examinations |
| Full-term group | – | Other: Structural, functional and metabolic eye examinations |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Born moderate-to-late preterm.
- Born in Gothenburg, Sweden.
- Born between years 2002 and 2004.
Key exclusion criteria (7 listed)
- Chromosomal abnormalities.
- Syndromes.
- Severe malformations.
- Asphyxia.
- Language difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural, functional and metabolic eye examinationsStructural, functional and metabolic eye examinations | Other | Full-term group, Moderate-to-late preterm group |
Primary outcome
Optic disc area.
Time frame: Through study completion, an average of 6 months
Optic disc area measured with Optical coherence tomography (OCT, Topcon).
Visual acuity.
Time frame: Through study completion, an average of 6 months.
Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.
Blood pressure.
Time frame: Through study completion, an average of 6 months.
Systolic and diastolic blood pressure measured with blood pressure cuffs.
Blood concentration of Hemoglobin A1c (HbA1c).
Time frame: Through study completion, an average of 6 months.
Blood samples of HbA1c.
Autism Spectrum Screening Questionnaire (ASSQ).
Time frame: 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).
Pediatric Quality of Life Inventory (PedsQL).
Time frame: 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).
Weight.
Time frame: Through study completion, an average of 6 months
Weight measured in kilograms.
The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV).
Time frame: 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).
Refraction.
Time frame: Through study completion, an average of 6 months.
Visual refraction measured with an autorefractor (Topcon).
Height.
Time frame: Through study completion, an average of 6 months.
Height measured in meters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Visual Impairment, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic disc area. (time frame: Through study completion, an average of 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.