Late neonatal neurological outcome in infants with prenatally diagnosed duct dependent CHD and its relation with fetal and neonatal cerebral perfusion

Congenital heart disease (CHD) is a common congenital disorder that often leads
to neurodevelopmental compromise and potentially a low quality of life. There
is increasing evidence that brain damage, which leads to neurodevelopmental
compromise, not only occurs during cardiothoracic corrective surgery, but
already occurs during early life or even before birth in infants with CHD. In
order to prevent brain damage, it is important to know the exact timing of
brain damage in CHD. As yet, the exact timing of brain damage in CHD is
unknown. To gain more insight in cerebral perfusion in fetuses with prenatally
diagnosed CHD, antenatal Doppler flow profiles are routine clinical care at the
University Medical Center Groningen (UMCG). Furthermore, postnatally and during
cardiothoracic corrective surgery, near-infrared Spectroscopy (NIRS) is a
reliable and non-invasive method to assess cerebral and systemic oxygen
saturation, which reflects cerebral and systemic perfusion. However, the
combination of antenatal Doppler flow profiles and postnatal and peri-operative
continuous cerebral and systemic oxygen saturation measured by NIRS has never
been studied in relation to late neonatal outcome in infants with prenatally
diagnosed CHD. Late neonatal outcome can be assessed using the qualitative
assessment of general movements (GMs) according to Prechtl*s method. The
relation between antenatal Doppler flow profiles, postnatal and peri-operative
cerebral and systemic oxygen saturation and late neonatal neurological outcome
could provide more insight into the timing of brain damage in infants with CHD.

First objective: To assess late neonatal neurological outcome in infants with
duct dependent CHD and to gain more insight into the timing of brain damage. We
will determine whether the quality of GMs at an age of seven days and three
months is associated with antenatal Doppler flow profiles in infants with
prenatally diagnosed duct dependent CHD. Furthermore, we will determine the
relation between the quality of GMs at an age of seven days and three months
and postnatal continuous cerebral and systemic oxygen saturation measured by
NIRS in infants with prenatally diagnosed congenital heart disease. Secondary
objective: To assess whether antenatal Doppler flow profiles are associated
with postnatal cerebral and systemic oxygen saturation measured by NIRS.
Furthermore, we will analyze the effect of peri-operative NIRS monitoring on
GMs by comparing general movements at an age of seven days (pre-operative) to
GMs at an age of three months (post-operative).

Prospective observational cohort study.

This study is an observational study, implying minimal extra care; therefore
there is almost no burden or risk associated with participation. The study
contains three major parameters, i.e. GMs, postnatal and peri-operative
continuous multisite NIRS, and antenatal Doppler Flow profiles.
Firstly, GMs is a widely accepted non-invasive method to assess neurological
neonatal outcome. At an age of seven days, a camera will be placed in a way
that caregivers are not hindered by the camera and do not lose sight on the
monitor. Therefore, measurement of GMs at an age of seven days will not
interfere with clinical care. At an age of three months the infant will be
filmed during an outpatient clinical visit or at home. The infant has to be
relaxed and comfortable for a successful GMs analysis. The infant has to have
little clothes on (romper) so that every movement is visible. Temperature of
the environment will be adapted to this situation.
Secondly, postnatal continuous NIRS is non-invasive and monitoring rcSO2 is
routine clinical care in infants with CHD admitted to the NICU at the UMCG. For
the purpose of this study a second sensor will be placed on the left flank of
the infant using special bandages (Mepitel®) so that skin irritation is
avoided. The sensors will be placed and removed during routine handling
moments, so the infant is not disturbed.
Thirdly, antenatal Doppler flow profiles in foetuses with CHD are also
non-invasive and routine clinical care at the UMCG.
This study cannot be performed in another study population, because our
intention is to assess whether there is an association between GMs and
antenatal Doppler flow profiles, and postnatal and peri-operative continuous
NIRS monitoring in infants with prenatally diagnosed duct dependent CHD.
This study may provide more insight into the timing of brain damage in CHD,
which might be of importance to prevent brain damage and increase quality of
life of patients with CHD. We will compare our results with reference values
described in literature; no control group will be included.