Abstract
BackgroundChildren born preterm may display cognitive, learning, and behaviour difficulties as they grow up. In particular, very premature birth (gestation age between 28 and less than 32 weeks) may put infants at increased risk of intellectual deficits and attention deficit disorder. Evidence suggests that the basis of these problems may lie in difficulties in the development of executive functions. One of the earliest executive functions to emerge around 1 year of age is the ability to control attention. An eye-tracking-based cognitive training programme to support this emerging ability, the Attention Control Training (ACT), has been developed and tested with typically developing infants. The aim of this study is to investigate the feasibility of using the ACT with healthy very preterm (VP) infants when they are 12 months of age (corrected age). The ACT has the potential to address the need for supporting emerging cognitive abilities of VP infants with an early intervention, which may capitalise on infants’ neural plasticity.Methods/designThe feasibility study is designed to investigate whether it is possible to recruit and retain VP infants and their families in a randomised trial that compares attention and social attention of trained infants against those that are exposed to a control procedure. Feasibility issues include the referral/recruitment pathway, attendance, and engagement with testing and training sessions, completion of tasks, retention in the study, acceptability of outcome measures, quality of data collected (particularly, eye-tracking data). The results of the study will inform the development of a larger randomised trial.DiscussionSeveral lines of evidence emphasise the need to support emerging cognitive and learning abilities of preterm infants using early interventions. However, early interventions with preterm infants, and particularly very preterm ones, face difficulties in recruiting and retaining participants. These problems are also augmented by the health vulnerability of this population. This feasibility study will provide the basis for informing the implementation of an early cognitive intervention for very preterm infants.Trial registrationRegistered Registration ID: NCT03896490. Retrospectively registered at Clinical Trials Protocol Registration and Results System (clinicaltrials.gov).
Highlights
Children born preterm may display cognitive, learning, and behaviour difficulties as they grow up
Early interventions with preterm infants, and very preterm ones, face difficulties in recruiting and retaining participants. These problems are augmented by the health vulnerability of this population. This feasibility study will provide the basis for informing the implementation of an early cognitive intervention for very preterm infants
The Attention Control Training (ACT) meets this need for early interventions, targets key skills that are related to the development of cognitive flexibility and Executive Functions, and does so at an age whereby attention control abilities are just emerging and may be plastic and amenable to change [73]
Summary
Importance of the study The evidence of persisting intellectual and educational attainment deficits in children born VP [6, 15, 16] in spite of improvements in their care highlights the need for interventions that may enhance key foundational abilities at an early age. Determining the feasibility of a randomised controlled trial Infants born VP are a relatively small sub-group within the overall infant population: in England and Wales, they represent approximately 1% of live births every year, but this still represents a large number of infants affected by VP birth, e.g. over 5500 in England and Wales [47] These infants are often exposed to aversive events (e.g. long stay in the NICU) and may have complex needs, which affect the life and well-being of parents and families [3, 27]. The recruitment of this population in experimental studies and trials may present a series of challenges concerning identifying and contacting families affected by preterm birth, communicating in sensitive manners, challenges in participation and retention. Dissemination We will make public the results of the study via an open access journal publication, a final technical report and briefing for the funders of the study, and a plain English summary which we will send to all participants
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