IMPROVING GASTROINTESTINAL FUNCTION IN HIGH-RISK NEWBORNS BY STIMULATION OF THE ENTERIC NERVOUS SYSTEM

Infants born preterm or with congenital diaphragmatic hernia (CDH) are at risk
for several long-term unfavourable outcomes that can be related to feeding
difficulties from birth onwards. Adverse nutritional outcomes in both patient
groups mainly originate from mechanical dysfunction, based on dysmotility.
Mechanical function includes suck-swallow coordination, gastrointestinal
sphincter tone, gastric emptying and intestinal motility and is regulated by
the complex interplay of the autonomic (ANS) and enteric (ENS) nervous system
with modulation by the central nervous system (CNS). The intra-uterine
environment provides the fetus with developmentally timed sensory exposures
through *touch* that are necessary for development of sensory control and
autonomous coordination of bodily functions. Preterm infants miss out this
normal maturation, while newborns with CDH may exhibit a delayed maturation
probably as a result of the deviant anatomical situation and severe illness
during the direct postnatal period. In the postnatal situation both patient
groups may be confronted with either *negative* sensory stimulation through
exposures such as procedural touch/handling, pain or otherwise a reduction in
sensory exposures through avoidance of positive touch in relation to supposed
clinical instability. All together this may affect normal development and lead
to sensory deprivation and delayed maturation of the nervous regulation and
cerebral maturation. Tactile-kinaesthetic and oral sensorimotor stimulation
using positive gentle touch have been shown to positively affect
cardiorespiratory stability, weight gain, gastro-intestinal performance, and
length of stay in hospital for preterm infants. However, these strategies have
not been evaluated in high-risk infants. The current study aims at evaluating
an intervention programme that provides positive stimuli through touch adapted
to the stage of development of the infant with regard to timing, duration and
intensity that supports the maturational development of gastrointestinal
functionality. (Handling Adapted to Postnatal age with Tactile-kinaesthetic and
Oral sensorimotor Stimulation; HAPTOS intervention). We hypothesize that the
HAPTOS intervention will improve the postnatal maturation of the autonomous and
enteral nervous system and cause improvements in gastrointestinal motility,
enteral and oral feeding and cardiorespiratory stability.

Primary objective: determine whether HAPTOS intervention results in earlier
attainment (postnatal days) of full enteral feeding and/or full oral feeding
(postmenstrual age) compared to standard care.

Secondary objectives: To determine whether Haptos-intervention compared to
standard care results in different outcomes categorized as I. short term
clinical outcome II. Short term cardiorespiratory stability and autonomic
regulation III. Long-term growth and wellbeing IV. Long-term neurodevelopment
V. Parent participation

Open randomized clinical trial; multicenter

All infants will receive the standard of care according to the institutional
protocol, while the intervention group additionally will receive a predefined
structured daily set of HAPTOS intervention. Parents in the intervention group
will be offered to participate in the stimulation programme. Treatment will be
continued according to randomization if the patient is transferred to a
participating hospital or otherwise discontinued.

All infants in this study will receive standard care according to the
principles of individualized developmental care which currently belongs to
(inter-) national guidelines and is regarded as safe. The HAPTOS intervention
is non-invasive. All endpoints used in this study can and will be assessed
non-invasively within the current standard of care for high-risk infants. The
intended intervention of the current study differs only slightly from the
current standard of care. Stroking of body parts is often already practised
within the concept of developmental care. The current study aims to be an
advancement of routine developmental care and therefore we assume that
participation will not increase the risk for damage and participants even may
benefit from participation because the intervention intends to improve the
postnatal maturation of autonomous and enteral nervous system and
gastro-intestinal outcomes. This study is group related because the described
feeding difficulties is a condition that specifically concerns preterm infants
and newborns with CDH.