Evidence map›Paper›PMID 31915035›Full record

ArticleTrials2020

Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol.

Marlou J G Kooiker, Yoni van der Linden, Jenneke van Dijk, Ymie J van der Zee, Renate M C Swarte, Liesbeth S Smit, Sanny van der Steen-Kant, Sjoukje E Loudon, Irwin K M Reiss, Kees Kuyper and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
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  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Marlou J G KooikerDepartment of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands. m.kooiker@erasmusmc.nl.ORCID http://orcid.org/0000-0002-0433-0045
Yoni van der LindenRoyal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, the Hague, The Netherlands.
Jenneke van DijkRoyal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, the Hague, The Netherlands.
Ymie J van der ZeeRoyal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Rotterdam, The Netherlands.
Renate M C SwarteDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Liesbeth S SmitDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Sanny van der Steen-KantRoyal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Huizen, The Netherlands.
Sjoukje E LoudonDepartment of Pediatric Ophthalmology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Irwin K M ReissDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Kees KuyperRoyal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Rotterdam, The Netherlands.
Johan J M PelDepartment of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.
Johannes van der SteenDepartment of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.
Visio · NLErasmus MC - Sophia Children’s Hospital · NLErasmus MC · NL

Funding

Stichting NOVUM OI0342
6 · The paper itself

Abstract

backgroundAn increasing number of children are suffering from brain damage-related visual processing dysfunctions (VPD). There is currently a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually adaptive, and is paired with quantitative outcome assessments. Our aim is to investigate the effectiveness of this first visual intervention program for young children with (a risk of) VPD.

methodsThis is a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care, which involves an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consists of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to the specific needs of the child). Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA) or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). DISCUSSION: Through this randomized controlled trial we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to a child's specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life.

trial registrationNetherlands Trial Register: NTR6952. Registered 19 January 2018.

Indexed as

BrainChild DevelopmentChild, PreschoolCognitionFemaleFollow-Up StudiesHumansInfantMaleNetherlandsNeurodevelopmental DisordersPerceptual DisordersPremature BirthRandomized Controlled Trials as TopicSingle-Blind MethodTime FactorsBrain damageCerebral visual impairmentChildren born pretermEye trackingNeurological riskVisual attentionVisual habilitationVisual interventionVisual processing

Identifiers

PMID31915035
PMCPMC6950993
OpenAlexW3000817774

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.