Improvement of working memory, attention and concentration after neonatal intensive care: a randomized controlled intervention study

In 2001, we established a unique longitudinal, multidisciplinary follow-up
program for neonatal ECMO survivors. To date almost 400 patients aged 0-18
years have been recruited into this program; closely following their medical
health and development, including executive functions. Congenital diaphragmatic
hernia (CDH) patients form a high-risk subgroup amongst them. Neonatal ECMO
survivors and CDH patients (even those without ECMO treatment) generally have
normal intelligence but increased risk for learning problems. This affects
school functioning and quality of life. Problems with memory, attention, and
concentration have been reported and have been shown to increase as children
develop (*growing into deficits*). COGMED is an internationally used
computer-based cognitive training program that has been shown to improve
cognitive performance in children with executive function deficits.

• To evaluate short-term (directly after training) and long-term (12 months)
effects of cognitive rehabilitation on (working)memory, attention,
concentration, and quality of life; measured by neuropsychological assessments,
and reports by parents and teachers
• To evaluate the direct effects of cognitive rehabilitation on brain
connectivity; measured by functional MRI (fMRI) during a Sternberg item
recognition task (SIRP) working memory task

In this single-blind randomized controlled trial we will recruit children from
Dutch neonatal ECMO-centers in Rotterdam and Nijmegen. Assessment of children
in both study arms will be performed in Rotterdam prior to (T0), directly after
(T1) and 12 months after (T2) intervention using neuropsychological tests,
standardized questionnaires for parents, teachers and child, and fMRI while
performing the SIRP (at T0 and T1 only). Assessment at T0 and COGMED coaching
is performed by a psychologist; the researcher who performs the assessments at
T1 and T2 will be unaware of treatment allocation (single-blind).

The treatment group will undergo COGMED computer training at home and via the
Internet 5 days a week during 5 consecutive weeks. The training will be coached
by a trained postdoc psychologist.

The intervention does not have direct negative effects; it is an
internationally used treatment modality for children. The burden conists of
hospital visits (outpatient clinic), 3 times within 12 months. The visits take
approximately half a day. For the treatment group the burden also includes 5
weeks, 5 days per week, online training for 45 minutes each day. The treatment
group may have direct benefit from the study, the intervention can be offered
to controls if proven effective after the end of the study.
Being studied with fMRI might cause fear in the children, but they will be
prepared carefully including a mock scanning session. In our experience in a
study with children of the same age group, fear hardly occurs.
If COGMED-training is proven effective, it can be offered to all neonatal
ECMO-survivors and CDH patients who show performance problems with working
memory, attention and concentration and are therefore at risk for future
academic problems.