N/A
N=12
Attention Control Training (ACT) and Very Preterm Infants
Very Premature Baby
Bottom Line
View on ClinicalTrials.gov: NCT03896490 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Recruitment and Retention — 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attention Control Training (Behavioral); Control (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Queen's University, Belfast
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment and Retention |
5; 5 | — |
| SECONDARY Percentage of Training/Control Sessions Attended by Infants |
100; 100 | — |
| SECONDARY Percentage of Training/Control Sessions Completed by Infants |
73.16; 72.92 | — |
| SECONDARY Duration of Tasks Administered to Infants During Training/Control Sessions |
83.60; 75.07 | — |
| SECONDARY Percentage of Tasks Completed at Post-test |
80.95; 80.95 | — |
| SECONDARY Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments |
1.84; 1.21 | — |
| SECONDARY Performance During Training |
0.40 | — |
Summary
Infants' attention control, defined as the ability to select what to pay attention to, is a fundamental building block for developing learning abilities and behaviour self-regulation. Infants born before term (<37 weeks gestation) display delays in attention control, and these delays cause cascade effects that include learning difficulties and behaviour problems. Infants born before 32 weeks of gestation, known as very preterm (VP), are particularly at risk of persistent difficulties in attention.
A ground-breaking early intervention, the Attention Control Training (ACT), targets infants' attention control. The novelty of the ACT lies in engaging young infants in "brain-training" using a computer interface, which tracks infants' gaze direction and presents training visual stimuli appropriate to the infants' ability level. Results demonstrate ACT improves attention of typically developing infants, contributing to improvements in other cognitive abilities (e.g. memory), but ACT has not been tested in clinical populations such as VP infants.
The investigators are running a feasibility study of the ACT intervention amongst VP infants aged 1 year (corrected age for prematurity). This feasibility study is necessary in order to adapt the ACT material and presentation to VP infants, and in particular to investigate the acceptability of a Randomised Trial and its training schedule by parents of VP infants.
The proposed study will allow the investigators to identify solutions to problems, ensuring the ACT material and delivery are customised for VP infants.
Eligibility Criteria
Inclusion Criteria
- Infants born very preterm (gestational age 28 to less than 32 weeks);
- Infant's family residing in Northern Ireland;
- Infant's age 12 months (+/- 1 month) at the start of the study, corrected for prematurity
Exclusion Criteria
- Significant visual and/or hearing disabilities;
- Congenital anomalies that may impact on their cognitive and sensory-motor development;
- A diagnosis of Cerebral Palsy;
- Infant taking part in a trial (or have recently taken part in a trial) which may interfere with this study (e.g. by affecting concentration abilities or representing a significant burden for the family).
Data sourced from ClinicalTrials.gov (NCT03896490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.