Supporting and Enhancing NICU Sensory Experiences (SENSE) (SENSE)

• ClinicalTrials.gov Identifier: NCT03316547
• Recruitment Status: Completed
• First Posted: October 20, 2017
• Results First Posted: July 7, 2021
• Last Update Posted: July 7, 2021
• Sponsor: Washington University School of Medicine
• Collaborator: University of Southern California
• Information provided by (Responsible Party): Washington University School of Medicine

Tracking Information

• First Submitted Date: August 15, 2017
• First Posted Date: October 20, 2017
• Results First Submitted Date: June 14, 2021
• Results First Posted Date: July 7, 2021
• Last Update Posted Date: July 7, 2021
• Actual Study Start Date: August 16, 2017
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2021)

• Ages and Stages Questionnaire (ASQ) - Communication at 1 Year [ Time Frame: One year corrected age ]
  Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
• Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age [ Time Frame: At term equivalent age (35-41 weeks PMA) ]
  Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome.

Original Primary Outcome Measures (submitted: October 16, 2017)

• Sensory Exposure [ Time Frame: Daily logging from time of study enrollment (sometime between 23-32 weeks post menstrual age) until discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  Logging sheets will be placed at the infant's bedside to document the daily execution (or lack thereof) of sensory-based interventions, who conducted the intervention (parent, member of research team, or other caregiver), as well as the infant's responses and consequences of the intervention.
• Sensory Exposure [ Time Frame: 24 hour period within 2 weeks of birth, at 30 and 34 weeks post menstrual age, and again at term equivalent age (36-40 weeks post menstrual age). ]
  Videotaping of a 24 hour period within 2 weeks of birth, at 30 and 34 weeks postmenstrual age, and again at term equivalent will be conducted. Videotaping at the infant's bedside will record daily exposure to sensory-based intervention and ensure consistency of the intervention to enable post hoc evaluation of differences in sensory exposure across the two groups.

Current Secondary Outcome Measures (submitted: June 14, 2021)

• Language Environmental Acquisition Device (LENA) [ Time Frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. ]
  Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure.
• Sensory Exposures Provided During Hospitalization [ Time Frame: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months). ]
  During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete.
• Dubowitz/Hammersmith Neonatal Neurological Evaluation [ Time Frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. ]
  At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome.
• General Movement Assessment (GMA) [ Time Frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. ]
  A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis.
• Discharge Questionnaire [ Time Frame: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age). ]
  Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, & difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below.
• 1 Year Follow-Up Questionnaire [ Time Frame: One year corrected age. ]
  The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable.
• Mother-Infant Interaction (at 1 Year Follow-up) [ Time Frame: One year corrected age. ]
  At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction.
• Parent Engagement During Hospitalization [ Time Frame: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months). ]
  On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care.
• Language Environmental Acquisition Device (LENA) Adult Word Count [ Time Frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. ]
  Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording.
• Percentage of Sensory Interventions Received [ Time Frame: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age). ]
  Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented.

Original Secondary Outcome Measures (submitted: October 16, 2017)

• Language Environmental Acquisition Device (LENA) [ Time Frame: Single 16 hour period to capture language and sound exposure will also occur at birth, 30, and 34 weeks, and again at term equivalent age (36-40 weeks post menstrual age). ]
  Audio recordings of a single 16 hour period to capture language and sound exposure will also occur at birth, 30, and 34 weeks, and again at term equivalent age using the Language Environmental Acquisition Device (LENA).
• NICU Network Neurobehavioral Scale (NNNS) [ Time Frame: At term equivalent age (between 36-40 weeks post menstrual age), just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  At term equivalent age (between 36-40 weeks postmenstrual age), prior to hospital discharge, infants will undergo a comprehensive neurobehavioral assessment using the NICU Network Neurobehavioral Scale (NNNS). The NNNS takes approximately 20 minutes to administer, is conducted at the infant's bedside in the hosptial, and has scaled scoring for many domains of function including: habituation, orientation, self-regulation, hypertonia, hypotonia, asymmetry, non-optimal reflexes, excitability, lethargy, arousal, quality of movements, stress, and tolerance of handling.
• Dubowitz [ Time Frame: At term equivalent age (between 36-40 weeks post menstrual age), just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  At term equivalent age (between 36-40 weeks postmenstrual age), prior to hospital discharge, infants will undergo a comprehensive neurobehavioral assessment using the Dubowitz to assess neurobehavior & movement quality.
• General Movement Assessment (GMA) [ Time Frame: At term equivalent age (between 36-40 weeks post menstrual age), just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  At term equivalent age (between 36-40 weeks postmenstrual age), prior to hosptial discharge, infants will be assessed using the General Movement Assessment (GMA) to assess movement quality.
• Neonatal Eating Outcome (NEO) [ Time Frame: At term equivalent age (between 36-40 weeks post menstrual age), just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  At term equivalent age (between 36-40 weeks postmenstrual age), prior to hosptial discharge, infants will be assessed using the Neonatal Eating Outcome (NEO) Assessment to assess infant feeding.
• Neonatal Oral Motor Assessment Scale (NOMAS) [ Time Frame: At term equivalent age (between 36-40 weeks post menstrual age), just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  At term equivalent age (between 36-40 weeks postmenstrual age), prior to hospital discharge, infants will be assessed using the Neonatal Oral Motor Assessment Scale (NOMAS) to assess infant feeding.
• Mother-infant interaction (at discharge) [ Time Frame: Just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  Prior to discharge from the hospital, a video recording of the mother feeding her infant will be obtained to assess parent-infant interaction.
• Discharge Questionnaire [ Time Frame: Just prior to discharge from the hospital (sometime between 32-60 weeks post menstrual age). ]
  Prior to discharge from the hospital, the infant's mother will complete a set of questionnaires, either online via REDCap survey or paper hard copies. This parent self-report measure takes approximately 15-20 minutes to complete.
• 1 Year Follow-Up Questionnaire [ Time Frame: One year corrected age. ]
  Long-term follow up will occur at one year corrected age. The parents of participants will be sent a set of questionnaires to complete, either online via REDCap survey or paper hard copies. This parent self-report measure takes approximately 30-45 minutes to complete.
• Mother-infant interaction (at 1 year follow-up) [ Time Frame: One year corrected age. ]
  At one year follow-up, parents will also be requested to send in a video of the mother feeding the child to assess parent-infant interaction.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: October 16, 2017)

Medical Records [ Time Frame: Birth to 5 years of age. ]

Medical information from the electronic medical record will be collected. The medical record may be accessed up until 5 years of age to document comprehensive patient information.

Descriptive Information

• Brief Title: Supporting and Enhancing NICU Sensory Experiences (SENSE)
• Official Title: Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants
• Brief Summary: Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.

Detailed Description

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, 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 in the NICU. 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.

Results from a rigorous systematic review, benchmarking, and expert opinion were 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) includes evidenced-based interventions that can be conducted by parents with their preterm infants across postmenstrual age while hospitalized. The sensory-based intervention includes the provision of specific amounts of auditory, tactile, vestibular, kinesthetic, olfactory, 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, focus groups of a multidisciplinary team of health care professionals and parents of preterm infants in the NICU, and a pilot/feasibility study were conducted to assess acceptability, appropriateness and feasibility of the sensory-based intervention plan. The investigators enrolled 30 very preterm infants within the first week of life and implemented the sensory-based program. Logging sheets were 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), and 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 were recorded by caregivers during interventions on the bedside logs. Negative sequelae of the intervention resulted in stopping the intervention and modifying the criteria for sensory-based interventions accordingly. A licensed therapist provided guidance as to when infants can and cannot tolerate sensory exposures. From clinical documentation and bedside logging, implementation factors were assessed. Adaptations to the sensory-based program were made until it was deemed appropriate by the investigative team. This occurred after the model for an enhanced sensory environment could be documented 75% of the time on at least 3 consecutive participants.

The aim of this randomized clinical trial was to 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 were 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 were educated and supported to conduct sensory interventions with their infants using the systematized protocol. The traditional care group had therapists and nurses provide and educate parents about sensory exposures as standard of care. For both care groups, infant neurobehavior, sensory processing, mother-infant interaction, and parent mental health were assessed at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year corrected using standardized measures. Differences between groups were explored.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

SENSE program-treatment; standard-of-care-control

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:

Parents were asked to participate in a study investigating 2 different approaches to sensory exposures in the NICU. The approach (SENSE or standard of care) were described after enrollment, based on which group they were randomized to. The evaluator was blinded to treatment assignment.

Primary Purpose: Treatment

• Condition: Premature Birth of Newborn

Intervention

Other: SENSE Program

Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. 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. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.

Other Name: Sensory-Based Intervention

Study Arms

• No Intervention: Control
  The control group received standard hospital care.
• Experimental: Intervention
  Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.
  Intervention: Other: SENSE Program

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Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2019): 70
• Original Estimated Enrollment (submitted: October 16, 2017): 62
• Actual Study Completion Date: November 1, 2019
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 32 Weeks (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03316547
• Other Study ID Numbers: 201601057
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Washington University School of Medicine
• Original Responsible Party: Roberta Pineda, Washington University School of Medicine, Assistant Professor
• Current Study Sponsor: Washington University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: University of Southern California

Investigators

• Principal Investigator: Roberta G Pineda, PhD, OTR/L; Washington University School of Medicine; University of Southern California

• PRS Account: Washington University School of Medicine
• Verification Date: June 2021