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Supporting and Enhancing NICU Sensory Experiences (SENSE)

Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03316547
Acronym
SENSE
Enrollment
70
Registered
2017-10-20
Start date
2017-08-16
Completion date
2019-11-01
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth of Newborn

Keywords

preterm

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.

Interventions

OTHERSENSE 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.

Sponsors

University of Southern California
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ages and Stages Questionnaire (ASQ) - Communication at 1 YearOne year corrected ageParents 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 AgeAt 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.

Secondary

MeasureTime frameDescription
Dubowitz/Hammersmith Neonatal Neurological EvaluationAt 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)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 QuestionnaireJust 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 QuestionnaireOne 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.
Language Environmental Acquisition Device (LENA)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.
Parent Engagement During HospitalizationEvery 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 CountSingle 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 ReceivedSensory 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.
Mother-Infant Interaction (at 1 Year Follow-up)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.
Sensory Exposures Provided During HospitalizationSensory 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
The control group received standard hospital care.
39
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. 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.
31
Total70

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath31
Overall StudyLost to Follow-up66
Overall StudyTransfer to another hospital64
Overall StudyWithdrawal by Subject32

Baseline characteristics

CharacteristicInterventionTotalControl
Age, Categorical
<=18 years
31 Participants70 Participants39 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous29.7 EGA at birth (weeks)
STANDARD_DEVIATION 2.6
29.6 EGA at birth (weeks)
STANDARD_DEVIATION 2.5
29.5 EGA at birth (weeks)
STANDARD_DEVIATION 2.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
13 Participants23 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
18 Participants47 Participants29 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
31 Participants70 Participants39 Participants
Sex: Female, Male
Female
19 Participants47 Participants28 Participants
Sex: Female, Male
Male
12 Participants23 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 391 / 31
other
Total, other adverse events
0 / 390 / 31
serious
Total, serious adverse events
0 / 390 / 31

Outcome results

Primary

Ages and Stages Questionnaire (ASQ) - Communication at 1 Year

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.

Time frame: One year corrected age

Population: As noted in Participant Flow module, overall number of participants analyzed reflects participants who completed testing at 1 year follow-up (decrease in participants due to death, transfer, and loss to follow-up).

ArmMeasureValue (MEAN)Dispersion
ControlAges and Stages Questionnaire (ASQ) - Communication at 1 Year38.6 score on a scaleStandard Deviation 18.1
InterventionAges and Stages Questionnaire (ASQ) - Communication at 1 Year48.6 score on a scaleStandard Deviation 10.3
Primary

Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age

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.

Time frame: At term equivalent age (35-41 weeks PMA)

Population: Overall number of participants analyzed reflects number of participants assessed at term equivalent age (some were lost at this time point for this assessment due to death or transfer to a different hospital).

ArmMeasureValue (MEAN)Dispersion
ControlNeonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age4.4 score on a scaleStandard Deviation 2.7
InterventionNeonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age4.1 score on a scaleStandard Deviation 2.2
Secondary

1 Year Follow-Up Questionnaire

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.

Time frame: One year corrected age.

Population: Number of participants analyzed reflects the number of received follow-up questionnaires at 1 year corrected age. Participants who died, transferred to a different NICU prior to discharge, or did not complete follow-up questionnaires were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Control1 Year Follow-Up QuestionnaireMaternal Confidence Questionnaire (range 0-56), Higher = more confidence51.4 score on a scaleStandard Deviation 5.2
Control1 Year Follow-Up QuestionnairePSI - Parental Distress (range 12-60), Higher = more dysfunction20.8 score on a scaleStandard Deviation 7.8
Control1 Year Follow-Up QuestionnairePSI - Difficult Child (range 12-60), higher = more dysfunction20.1 score on a scaleStandard Deviation 6.3
Control1 Year Follow-Up QuestionnaireBeck Depression Inventory (range 0-63), Higher = more depression3.6 score on a scaleStandard Deviation 4.1
Control1 Year Follow-Up QuestionnaireSTAI - State Anxiety (range 20-80), Higher = more anxiety33.7 score on a scaleStandard Deviation 9.6
Control1 Year Follow-Up QuestionnaireSTAI - Trait Anxiety (range 20-80), Higher = more anxiety35.8 score on a scaleStandard Deviation 9.3
Control1 Year Follow-Up QuestionnairePSI - Defensive Responding (range 7-35), Higher = more dysfunction11.9 score on a scaleStandard Deviation 4.4
Control1 Year Follow-Up QuestionnaireICQ - Mom and Baby (range 0-5), higher = better care4.2 score on a scaleStandard Deviation 0.9
Control1 Year Follow-Up QuestionnaireICQ - Emotionality (range 0-5), higher = better care4.1 score on a scaleStandard Deviation 0.9
Control1 Year Follow-Up QuestionnaireICQ - Responsiveness (range 0-5), higher = better care4.5 score on a scaleStandard Deviation 1
Control1 Year Follow-Up QuestionnaireASQ - Communication (range 0-60), Higher = better38.6 score on a scaleStandard Deviation 18.1
Control1 Year Follow-Up QuestionnaireASQ - Problem Solving (range 0-60), Higher = better35.8 score on a scaleStandard Deviation 20.4
Control1 Year Follow-Up QuestionnaireASQ - Gross Motor (range 0-60), Higher = better34.1 score on a scaleStandard Deviation 22.6
Control1 Year Follow-Up QuestionnaireASQ - Fine Motor (range 0-60), higher = better46.5 score on a scaleStandard Deviation 10.4
Control1 Year Follow-Up QuestionnaireASQ - Personal-Social (range 0-60), higher = better36.0 score on a scaleStandard Deviation 17.8
Control1 Year Follow-Up QuestionnaireSensory Profile - Touch (range 10-50), higher = more dysfunction16.9 score on a scaleStandard Deviation 6.2
Control1 Year Follow-Up QuestionnaireSensory Profile - Auditory (range 7-35), Higher = more dysfunction9.7 score on a scaleStandard Deviation 4.6
Control1 Year Follow-Up QuestionnaireSensory Profile - Visual (range 8-40), Higher = more dysfunction22.0 score on a scaleStandard Deviation 4.3
Control1 Year Follow-Up QuestionnaireSensory Profile - Movement Processing (range 6-30), Higher = more dysfunction18.8 score on a scaleStandard Deviation 3.8
Control1 Year Follow-Up QuestionnaireSensory Profile - Oral (range 7-35), higher = more dysfunction11.4 score on a scaleStandard Deviation 4.7
Control1 Year Follow-Up QuestionnaireSensory Profile - General (range 10-50), Higher = more dysfunction14.2 score on a scaleStandard Deviation 6.6
Control1 Year Follow-Up QuestionnaireSensory Profile - Behavior (range 6-30), Higher = more dysfunction10.6 score on a scaleStandard Deviation 5.3
Control1 Year Follow-Up QuestionnairePediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction54.1 score on a scaleStandard Deviation 31.6
Control1 Year Follow-Up QuestionnaireBehavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction55.4 score on a scaleStandard Deviation 16.2
Intervention1 Year Follow-Up QuestionnairePediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction61.2 score on a scaleStandard Deviation 28.7
Intervention1 Year Follow-Up QuestionnairePSI - Defensive Responding (range 7-35), Higher = more dysfunction11.7 score on a scaleStandard Deviation 7
Intervention1 Year Follow-Up QuestionnaireASQ - Gross Motor (range 0-60), Higher = better42.8 score on a scaleStandard Deviation 19.6
Intervention1 Year Follow-Up QuestionnairePSI - Parental Distress (range 12-60), Higher = more dysfunction20.6 score on a scaleStandard Deviation 11.6
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Movement Processing (range 6-30), Higher = more dysfunction20.3 score on a scaleStandard Deviation 2.9
Intervention1 Year Follow-Up QuestionnairePSI - Difficult Child (range 12-60), higher = more dysfunction17.8 score on a scaleStandard Deviation 8.1
Intervention1 Year Follow-Up QuestionnaireASQ - Fine Motor (range 0-60), higher = better47.8 score on a scaleStandard Deviation 14
Intervention1 Year Follow-Up QuestionnaireBeck Depression Inventory (range 0-63), Higher = more depression3.9 score on a scaleStandard Deviation 5.9
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Behavior (range 6-30), Higher = more dysfunction11.2 score on a scaleStandard Deviation 3.6
Intervention1 Year Follow-Up QuestionnaireSTAI - State Anxiety (range 20-80), Higher = more anxiety28.9 score on a scaleStandard Deviation 9
Intervention1 Year Follow-Up QuestionnaireASQ - Personal-Social (range 0-60), higher = better40.3 score on a scaleStandard Deviation 16.4
Intervention1 Year Follow-Up QuestionnaireSTAI - Trait Anxiety (range 20-80), Higher = more anxiety28.8 score on a scaleStandard Deviation 13.1
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Oral (range 7-35), higher = more dysfunction10.6 score on a scaleStandard Deviation 4.4
Intervention1 Year Follow-Up QuestionnaireMaternal Confidence Questionnaire (range 0-56), Higher = more confidence52.4 score on a scaleStandard Deviation 3.2
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Touch (range 10-50), higher = more dysfunction19.7 score on a scaleStandard Deviation 4.3
Intervention1 Year Follow-Up QuestionnaireICQ - Mom and Baby (range 0-5), higher = better care4.3 score on a scaleStandard Deviation 0.9
Intervention1 Year Follow-Up QuestionnaireBehavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction51.0 score on a scaleStandard Deviation 16.1
Intervention1 Year Follow-Up QuestionnaireICQ - Emotionality (range 0-5), higher = better care3.8 score on a scaleStandard Deviation 1.7
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Auditory (range 7-35), Higher = more dysfunction9.7 score on a scaleStandard Deviation 5
Intervention1 Year Follow-Up QuestionnaireICQ - Responsiveness (range 0-5), higher = better care4.6 score on a scaleStandard Deviation 1.1
Intervention1 Year Follow-Up QuestionnaireSensory Profile - General (range 10-50), Higher = more dysfunction13.9 score on a scaleStandard Deviation 6.1
Intervention1 Year Follow-Up QuestionnaireASQ - Communication (range 0-60), Higher = better48.6 score on a scaleStandard Deviation 10.3
Intervention1 Year Follow-Up QuestionnaireSensory Profile - Visual (range 8-40), Higher = more dysfunction21.6 score on a scaleStandard Deviation 4.2
Intervention1 Year Follow-Up QuestionnaireASQ - Problem Solving (range 0-60), Higher = better41.1 score on a scaleStandard Deviation 14.2
Secondary

Discharge Questionnaire

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.

Time frame: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).

Population: Questionnaires were included if complete; number of participants analyzed reflects number of completed questionnaires. Reasons for questionnaire incompletion were: infant death, transfer prior to discharge.

ArmMeasureGroupValue (MEAN)Dispersion
ControlDischarge QuestionnaireSensory Profile - Touch (range 3-15) - higher = possible dysfunction4.3 score on a scaleStandard Deviation 1.8
ControlDischarge QuestionnaireSensory Profile - Auditory (range 4-20) higher = possible dysfunction9.2 score on a scaleStandard Deviation 3.7
ControlDischarge QuestionnaireSensory Profile - Visual (range 4-20)higher = possible dysfunction6.7 score on a scaleStandard Deviation 4
ControlDischarge QuestionnaireSensory Profile - Movement (range 4-20) higher = possible dysfunction8.0 score on a scaleStandard Deviation 2
ControlDischarge QuestionnaireSensory Profile - Oral (range 2-10) higher = possible dysfunction4.6 score on a scaleStandard Deviation 1.9
ControlDischarge QuestionnaireSensory Profile - General (range 8-40) higher = possible dysfunction14.1 score on a scaleStandard Deviation 5.7
ControlDischarge QuestionnairePSI- Defensive Responding (range 7-35) Higher = more dysfunction13.3 score on a scaleStandard Deviation 5.4
ControlDischarge QuestionnairePSI - Parental Distress (range 12-60) Higher = more dysfunction22.7 score on a scaleStandard Deviation 7.7
ControlDischarge QuestionnairePSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction19.6 score on a scaleStandard Deviation 5.4
ControlDischarge QuestionnairePSI - Difficult Child (range 12-60) Higher = more dysfunction18.2 score on a scaleStandard Deviation 5.2
ControlDischarge QuestionnaireEdinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression9.0 score on a scaleStandard Deviation 4.7
ControlDischarge QuestionnaireParental Stressor Scale - NICU (range 0-5), Higher = more stress3.1 score on a scaleStandard Deviation 1.2
ControlDischarge QuestionnaireSTAI - State Anxiety (range 20-80) Higher = more anxiety38.5 score on a scaleStandard Deviation 11.9
ControlDischarge QuestionnaireSTAI - Trait Anxiety (range 20-80) Higher = more anxiety37.0 score on a scaleStandard Deviation 11.5
ControlDischarge QuestionnaireMaternal Confidence Questionnaire (range 0-56) Higher = more stress44.2 score on a scaleStandard Deviation 9
ControlDischarge QuestionnaireICQ - Mom and Baby (range 0-5), Higher = better care4.3 score on a scaleStandard Deviation 0.5
ControlDischarge QuestionnaireICQ - Emotionality (range 0-5), Higher = better care4.2 score on a scaleStandard Deviation 0.9
ControlDischarge QuestionnaireICQ - Responsiveness (range 0-5), Higher = better care3.7 score on a scaleStandard Deviation 0.8
InterventionDischarge QuestionnaireSTAI - Trait Anxiety (range 20-80) Higher = more anxiety34.8 score on a scaleStandard Deviation 14.7
InterventionDischarge QuestionnaireSensory Profile - Touch (range 3-15) - higher = possible dysfunction4.8 score on a scaleStandard Deviation 2.1
InterventionDischarge QuestionnairePSI - Difficult Child (range 12-60) Higher = more dysfunction17.4 score on a scaleStandard Deviation 5.7
InterventionDischarge QuestionnaireSensory Profile - Auditory (range 4-20) higher = possible dysfunction8.1 score on a scaleStandard Deviation 3.4
InterventionDischarge QuestionnaireICQ - Responsiveness (range 0-5), Higher = better care4.1 score on a scaleStandard Deviation 0.9
InterventionDischarge QuestionnaireSensory Profile - Visual (range 4-20)higher = possible dysfunction5.6 score on a scaleStandard Deviation 2.8
InterventionDischarge QuestionnaireEdinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression8.5 score on a scaleStandard Deviation 5.5
InterventionDischarge QuestionnaireSensory Profile - Movement (range 4-20) higher = possible dysfunction7.9 score on a scaleStandard Deviation 2.4
InterventionDischarge QuestionnaireMaternal Confidence Questionnaire (range 0-56) Higher = more stress49.1 score on a scaleStandard Deviation 7.6
InterventionDischarge QuestionnaireSensory Profile - Oral (range 2-10) higher = possible dysfunction4.2 score on a scaleStandard Deviation 1.7
InterventionDischarge QuestionnaireParental Stressor Scale - NICU (range 0-5), Higher = more stress2.5 score on a scaleStandard Deviation 1
InterventionDischarge QuestionnaireSensory Profile - General (range 8-40) higher = possible dysfunction14.9 score on a scaleStandard Deviation 5.6
InterventionDischarge QuestionnaireICQ - Emotionality (range 0-5), Higher = better care4.3 score on a scaleStandard Deviation 0.9
InterventionDischarge QuestionnairePSI- Defensive Responding (range 7-35) Higher = more dysfunction13.0 score on a scaleStandard Deviation 6.1
InterventionDischarge QuestionnaireSTAI - State Anxiety (range 20-80) Higher = more anxiety35.1 score on a scaleStandard Deviation 17.9
InterventionDischarge QuestionnairePSI - Parental Distress (range 12-60) Higher = more dysfunction22.6 score on a scaleStandard Deviation 10
InterventionDischarge QuestionnaireICQ - Mom and Baby (range 0-5), Higher = better care4.3 score on a scaleStandard Deviation 0.8
InterventionDischarge QuestionnairePSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction18.7 score on a scaleStandard Deviation 7.5
Secondary

Dubowitz/Hammersmith Neonatal Neurological Evaluation

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.

Time frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.

Population: The number of participants analyzed reflects the number of infants who underwent HNNE assessment at 35-41 weeks post menstrual age; some infants were not assessed at this time point due to death or transfer to a different hospital prior to NICU discharge.

ArmMeasureValue (MEAN)Dispersion
ControlDubowitz/Hammersmith Neonatal Neurological Evaluation22.8 score on a scaleStandard Deviation 4
InterventionDubowitz/Hammersmith Neonatal Neurological Evaluation20.6 score on a scaleStandard Deviation 3.4
Secondary

General Movement Assessment (GMA)

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.

Time frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.

Population: Video quality was insufficient for appropriate scoring and thus not analyzed.

Secondary

Language Environmental Acquisition Device (LENA)

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.

Time frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.

Population: Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues).

ArmMeasureGroupValue (MEAN)Dispersion
ControlLanguage Environmental Acquisition Device (LENA)% Distant words2.6 percentage of 16h recordingStandard Deviation 2.6
ControlLanguage Environmental Acquisition Device (LENA)% Noise12.5 percentage of 16h recordingStandard Deviation 9.7
ControlLanguage Environmental Acquisition Device (LENA)% TV or electronic sounds14.8 percentage of 16h recordingStandard Deviation 14
ControlLanguage Environmental Acquisition Device (LENA)% Silence67.7 percentage of 16h recordingStandard Deviation 17.8
ControlLanguage Environmental Acquisition Device (LENA)% Meaningful words2.4 percentage of 16h recordingStandard Deviation 1.5
InterventionLanguage Environmental Acquisition Device (LENA)% Silence68.0 percentage of 16h recordingStandard Deviation 18.5
InterventionLanguage Environmental Acquisition Device (LENA)% Meaningful words3.9 percentage of 16h recordingStandard Deviation 3
InterventionLanguage Environmental Acquisition Device (LENA)% Distant words3.7 percentage of 16h recordingStandard Deviation 2.6
InterventionLanguage Environmental Acquisition Device (LENA)% TV or electronic sounds14.3 percentage of 16h recordingStandard Deviation 17.4
InterventionLanguage Environmental Acquisition Device (LENA)% Noise10.2 percentage of 16h recordingStandard Deviation 9.1
Secondary

Language Environmental Acquisition Device (LENA) Adult Word Count

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.

Time frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.

Population: Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues).

ArmMeasureValue (MEAN)Dispersion
ControlLanguage Environmental Acquisition Device (LENA) Adult Word Count4618.1 wordsStandard Deviation 3934
InterventionLanguage Environmental Acquisition Device (LENA) Adult Word Count4338.5 wordsStandard Deviation 4818.8
Secondary

Mother-Infant Interaction (at 1 Year Follow-up)

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.

Time frame: One year corrected age.

Population: Overall number of participants analyzed reflects the number of participants who returned completed questionnaires at 1 year corrected age. Reasons for lack of completion included: death of infant, transfer to different hospital prior to NICU discharge, lost to follow-up (not responding to calls/mail).

ArmMeasureValue (MEAN)Dispersion
ControlMother-Infant Interaction (at 1 Year Follow-up)17.8 score on a scaleStandard Deviation 6.2
InterventionMother-Infant Interaction (at 1 Year Follow-up)14.3 score on a scaleStandard Deviation 6
Secondary

Parent Engagement During Hospitalization

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.

Time frame: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).

Population: Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge.

ArmMeasureGroupValue (MEAN)Dispersion
ControlParent Engagement During HospitalizationAverage number of days per 5-day week parents provided skin-to-skin care1.6 DaysStandard Deviation 1.6
ControlParent Engagement During HospitalizationAverage number of days per 5-day week parents visited3.9 DaysStandard Deviation 1.3
ControlParent Engagement During HospitalizationAverage number of days per 5-day week parents held infant3.7 DaysStandard Deviation 1.1
InterventionParent Engagement During HospitalizationAverage number of days per 5-day week parents visited3.9 DaysStandard Deviation 1.2
InterventionParent Engagement During HospitalizationAverage number of days per 5-day week parents held infant3.7 DaysStandard Deviation 1.3
InterventionParent Engagement During HospitalizationAverage number of days per 5-day week parents provided skin-to-skin care1.8 DaysStandard Deviation 1.7
Secondary

Percentage of Sensory Interventions Received

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.

Time frame: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).

Population: Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge.

ArmMeasureValue (MEAN)Dispersion
ControlPercentage of Sensory Interventions Received80.5 percentage of interventions receivedStandard Deviation 51.4
InterventionPercentage of Sensory Interventions Received122.7 percentage of interventions receivedStandard Deviation 34.9
Secondary

Sensory Exposures Provided During Hospitalization

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.

Time frame: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlSensory Exposures Provided During Hospitalization# of infants who received > 75% of recommended doses of sensory interventions14 Participants
ControlSensory Exposures Provided During Hospitalization# of infants who received 100% of recommended doses of sensory interventions8 Participants
ControlSensory Exposures Provided During HospitalizationParent provided > 50% of interventions received12 Participants
InterventionSensory Exposures Provided During Hospitalization# of infants who received > 75% of recommended doses of sensory interventions24 Participants
InterventionSensory Exposures Provided During Hospitalization# of infants who received 100% of recommended doses of sensory interventions15 Participants
InterventionSensory Exposures Provided During HospitalizationParent provided > 50% of interventions received12 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026