Supporting and Enhancing NICU Sensory Experiences (SENSE)

The birth of an infant is a time of excitement and joy. However, when an infant is born
preterm, parents often experience fear, anxiety, stress, and disappointment. Contrasting a
full-term birth, the preterm infant is initially separated from the family and thrust into a
medical environment, the neonatal intensive care unit (NICU), to sustain life. Parents are
often 'visitors', and the traditional parenting role is challenged. Difficulties in caring
for their infants further exacerbate their anxiety and stress, prompting coping through
withdrawing or avoiding participation in care. This can have long-term effects on the
infant's development and the parent-child relationship. While the preterm infant needs
medical care, they also have a great developmental need for human engagement, particularly
with their parents. Changing the model of care to fully engage and support parents in
providing developmentally appropriate, positive sensory-based exposures within the tenuous
NICU environment is possible and can result in positive benefits for both the infant and
family.

Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone.
Although survival rates of preterm infants have increased with advances in medical care, the
risk of developmental delay and disability has remained constant. Very preterm infants (<32
weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average
of three months after birth, which is a significant period of time coinciding with a critical
window of brain development. While medical factors, such as brain injury, can heighten the
risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious
effects on early brain structure and function.

The Influence of Early Environment: Maternal deprivation and isolation from positive sensory
experiences are prominent features of orphan studies. Consequences of language and human
deprivation include emotional disturbances, delayed cognitive and language skills, and
abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant
differs from a child who has been institutionalized or deprived of caregiving attention after
full term birth, there are similarities, such as the altered temporal lobe structures, and
the pattern of developmental impairments. There is growing evidence supporting the importance
of parents in the NICU. Low frequency visits between parents and their hospitalized preterm
infants have been associated with suboptimal outcomes, like child abuse and abandonment and
adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in
care from admission to discharge and have reported shorter hospitalizations. There is also a
growing body of evidence supporting positive sensory exposures for preterm infants, including
maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic
interventions. In addition, my team has made important research findings pointing to the
potential need for developmentally-appropriate sensory exposures in the NICU.

Outcomes Associated with Preterm Birth: While advances in medical technologies have improved
the rates of survival among preterm infants, the risk of long-term morbidities remains high,
with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor
problems, language and communication problems are common in former preterm infants when
studied at school age, and recent evidence suggests that language deficits persist through
childhood. Language difficulties have also been shown to affect a broad range of factors
important for social prowess and academic achievement. In addition, preterm infants have a
heightened risk of attachment disorders and other social-emotional problems.

Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are
associated with parenting a preterm infant, including depression, anxiety, and post-traumatic
stress. Such negative parental mental health outcomes proceed to influence the parent-child
relationship, leading to a parent's inability to recognize infant cues as well as increased
negativity and intrusiveness. Negative maternal-child interactions continue into the first
several months of life if stress remains high. Forming such a foundation may then lead to
negative child outcomes associated with social-emotional development, including attachment
insecurity, and mental health issues.

Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the
NICU are exposed to significant stressors that include painful procedures, disruption of
normal sensory experiences, and stress related to parent-infant separation. In addition to
the loss of parental nurturing, there is growing concern that stress during a period of
extensive brain development may result in permanent and deleterious developmental outcomes.

Developmental care, which includes sensory minimization, has been the predominant model of
care in the NICU since the 1980s, because the bright and noisy environment, which exceeds
sensory standards set by the American Academy of Pediatrics, is understood to adversely
affect growth and development of the preterm infant. In support of developmental care
principles, NICU staff makes efforts to reduce modifiable stimuli to the high risk infant in
the NICU. However, developmental care has mixed results. There is emerging research on the
positive effects of sensory stimulation for preterm infants in the NICU.

Positive sensory exposures in the NICU are critical, as they can have life-long implications
on learning, memory, emotions, and developmental progression. In an environment where stimuli
are primarily negative, it is especially important to define and implement positive sensory
exposures. Further, it is well understood that multi-dimensional sensory exposures are
present in utero in the final months and weeks of pregnancy, but the preterm infant misses
potentially important, timed exposures that may be absent or altered in the NICU environment.
Positive forms of sensory exposure during periods of infant readiness may be important to
facilitate appropriate neural pathways and enable positive experiences.

While evidence is emerging on the importance of positive sensory experiences in the NICU,
mostly in response to developmental care principles and to promote better outcomes, hospitals
around the globe are providing private rooms for infants and families. The private room can
decrease sensory exposure and provide a quiet, intimate environment for parents to engage
with their infants. However, my team demonstrated there are some drawbacks to private rooms.

Specific Aim #1: Define the type and timing of optimal sensory exposure for very preterm
infants hospitalized in the NICU and evaluate the implementation of an intentional sensory
exposure plan.

Results from a rigorous systematic review, benchmarking, and expert opinion are being used to
develop a clinical practice guideline for sensory-based interventions for hospitalized, very
preterm infants using the Appraisal of Guidelines for Research and Evaluation II instrument.
The manualized intervention, from the integrative review and development of the
implementation plan, set to be completed by November 2015 (funding from the University
Research Strategic Alliance), will include evidenced-based interventions that can be
conducted by parents with their preterm infants across postmenstrual age while hospitalized
(see Appendix 1 for a working model of the intervention plan). The sensory-based intervention
will include the provision of specific amounts of auditory, tactile, vestibular, kinesthetic,
and visual exposure to be conducted daily through hospitalization. The intervention plan is
intended to be implemented by parents (when available), and by surrogates when the parents
are unable to be present in the hospital. Surveys and focus groups of a multidisciplinary
team of health care professionals and parents of preterm infants in the NICU are being
conducted to assess acceptability, appropriateness and feasibility of the sensory-based
intervention plan.

The investigators will enroll 30 very preterm infants within the first week of life after
obtaining informed consent from the family at St. Louis Children's Hospital. Thirty infants
will enable implementation of the intervention with adequate participants to make
modifications and establish feasibility, while enabling those enrolled last to benefit from
the finalized intervention after all modifications are made. The study site has a commitment
to continuous change that will improve care as well as a track record of successful
implementation science projects. Members of the research team (occupational therapists,
physical therapists and psychologists) will instruct caregivers about the manualized
sensory-based intervention plan. Additional support from the research team will be provided
for caregivers daily or weekly, as needed. When available, parents will be encouraged to
carry out the sensory-based interventions with their infant. A member of the research team or
another surrogate (Child Life, volunteers, alternate family members, graduate students, or
interns) will conduct the defined sensory interventions and model the protocol for the
parents when the parents are unable to fully engage in care. My research team will initiate,
educate and act as models as well as will assess the implementation outcomes in this phase.

Logging sheets will be placed at the infant's bedside to document the execution of
sensory-based interventions, who conducted the intervention (parent, member of research team
or other caregiver), infant responses and consequences of the intervention. Physiological
(such as heart rate and oxygen saturation fluctuations), state (levels of arousal) and
behavioral (such as crying, changes in motoric tone) responses will be recorded by caregivers
during interventions on the bedside logs. Negative sequelae of the intervention will result
in stopping the intervention and modifying the criteria for sensory-based interventions
accordingly. A licensed therapist will provide guidance as to when infants can and cannot
tolerate sensory exposures. From clinical documentation and bedside logging, implementation
cost, penetration, and sustainability will be assessed. Nurses and parents will also be
questioned to define caregiver perceptions and time commitment. At least 2 focus groups with
health care professionals and parents of preterm infants will be conducted to assess
perceptions and to incorporate feedback into the intervention plan. Adaptations to the model
for an enhanced sensory environment will be made until it is deemed appropriate by the
investigative team. This will occur when the model for an enhanced sensory environment can be
documented through a minimum of 75% of hospitalization on at least 3 consecutive
participants.

Specific Aim #2: Assess the effect of a sensory-based intervention in the NICU on outcomes of
preterm infants and their families.

After obtaining informed consent, 70 preterm infants will be randomized to 2 levels of
sensory exposure: the sensory-based intervention or traditional care group. The parents of
infants in the sensory-based intervention group will be educated and supported to conduct
sensory interventions with their infants using the systematized protocol. The standard of
care group will have therapists and nurses provide and educate parents about sensory
exposures. For both care groups, infant neurobehavior and feeding, sensory processing,
mother-infant interaction, and parent mental health will be assessed at term age prior to
hospital discharge. Child development, sensory processing, and parent mental health will be
measured again at age one year corrected using standardized measures. Differences between
groups will be explored.

Inclusion Criteria:

Preterm Infants:

- A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks
gestation at the St. Louis Children's Hospital in St. Louis, Missouri.

- Infant is less than or equal to 7 days old when approached about the study.

Parents:

-Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less
than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis,
Missouri.

Exclusion Criteria:

Preterm Infants:

- Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV,
TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)

- Infants that are wards of the state, or become wards of the state after enrolling in
the study. Any data collected beginning at the time the state obtains custody onward
will not be used in the research study.

- Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the
significant variation in sensory exposure among those infants, and also to provide
consistency during the hospital's impending transition to strictly private rooms in
the very near future).

Parents:

-Parents with limited or no understanding of the English Language