Perra Oliver, Wass Sam, McNulty Alison, Sweet David, Papageorgiou Kostas, Johnston Matthew, Patterson Aaron, Bilello Delfina, Alderdice Fiona
1School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Building, 97 Lisburn Road, Belfast, BT9 7BL Northern Ireland, UK.
2Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, Northern Ireland, UK.
Pilot Feasibility Stud. 2020 Feb 10;6:17. doi: 10.1186/s40814-020-0556-9. eCollection 2020.
Children 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/DESIGN: The 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.
Several 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.
Registered Registration ID: NCT03896490. Retrospectively registered at Clinical Trials Protocol Registration and Results System (clinicaltrials.gov).
早产出生的儿童在成长过程中可能会出现认知、学习和行为方面的困难。特别是极早产(胎龄在28至不足32周之间)可能会使婴儿出现智力缺陷和注意力缺陷障碍的风险增加。有证据表明,这些问题的根源可能在于执行功能发育方面的困难。最早在1岁左右出现的执行功能之一是控制注意力的能力。一种基于眼动追踪的认知训练项目——注意力控制训练(ACT)已被开发出来,并在发育正常的婴儿中进行了测试,以支持这种新兴能力。本研究的目的是调查在健康的极早产(VP)婴儿12个月大(矫正年龄)时使用ACT的可行性。ACT有可能通过早期干预来满足支持VP婴儿新兴认知能力的需求,这可能利用婴儿的神经可塑性。
方法/设计:该可行性研究旨在调查在一项随机试验中招募并留住VP婴儿及其家庭是否可行,该试验将训练婴儿的注意力和社交注意力与接受对照程序的婴儿进行比较。可行性问题包括转诊/招募途径、出勤率、参与测试和训练课程的情况、任务完成情况、在研究中的留存率、结果测量的可接受性、所收集数据的质量(特别是眼动追踪数据)。研究结果将为更大规模随机试验的开展提供参考。
多条证据强调了使用早期干预来支持早产儿新兴认知和学习能力的必要性。然而,对早产儿,尤其是极早产儿的早期干预在招募和留住参与者方面面临困难。这一人群的健康脆弱性也加剧了这些问题。这项可行性研究将为对极早产儿实施早期认知干预提供依据。
注册登记号:NCT03896490。在临床试验协议注册和结果系统(clinicaltrials.gov)进行回顾性注册。