Trial Outcomes & Findings for Supporting and Enhancing NICU Sensory Experiences (SENSE) (NCT NCT03316547)

Last Updated: 2021-07-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

One year corrected age

Results posted on

2021-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Control The control group received standard hospital care.	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.
Overall Study STARTED	39	31
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	18	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Control The control group received standard hospital care.	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.
Overall Study Death	3	1
Overall Study Lost to Follow-up	6	6
Overall Study Withdrawal by Subject	3	2
Overall Study Transfer to another hospital	6	4

Baseline Characteristics

Supporting and Enhancing NICU Sensory Experiences (SENSE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=39 Participants The control group received standard hospital care.	Intervention n=31 Participants 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.	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=5 Participants	31 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.5 EGA at birth (weeks) STANDARD_DEVIATION 2.5 • n=5 Participants	29.7 EGA at birth (weeks) STANDARD_DEVIATION 2.6 • n=7 Participants	29.6 EGA at birth (weeks) STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	18 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	31 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Control n=21 Participants The control group received standard hospital care.	Intervention n=18 Participants 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.
Ages and Stages Questionnaire (ASQ) - Communication at 1 Year	38.6 score on a scale Standard Deviation 18.1	48.6 score on a scale Standard Deviation 10.3

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age	4.4 score on a scale Standard Deviation 2.7	4.1 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Control n=17 Participants The control group received standard hospital care.	Intervention n=12 Participants 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.
Language Environmental Acquisition Device (LENA) % Meaningful words	2.4 percentage of 16h recording Standard Deviation 1.5	3.9 percentage of 16h recording Standard Deviation 3.0
Language Environmental Acquisition Device (LENA) % Distant words	2.6 percentage of 16h recording Standard Deviation 2.6	3.7 percentage of 16h recording Standard Deviation 2.6
Language Environmental Acquisition Device (LENA) % TV or electronic sounds	14.8 percentage of 16h recording Standard Deviation 14.0	14.3 percentage of 16h recording Standard Deviation 17.4
Language Environmental Acquisition Device (LENA) % Noise	12.5 percentage of 16h recording Standard Deviation 9.7	10.2 percentage of 16h recording Standard Deviation 9.1
Language Environmental Acquisition Device (LENA) % Silence	67.7 percentage of 16h recording Standard Deviation 17.8	68.0 percentage of 16h recording Standard Deviation 18.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Sensory Exposures Provided During Hospitalization # of infants who received > 75% of recommended doses of sensory interventions	14 Participants	24 Participants
Sensory Exposures Provided During Hospitalization # of infants who received 100% of recommended doses of sensory interventions	8 Participants	15 Participants
Sensory Exposures Provided During Hospitalization Parent provided > 50% of interventions received	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Dubowitz/Hammersmith Neonatal Neurological Evaluation	22.8 score on a scale Standard Deviation 4.0	20.6 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Discharge Questionnaire Sensory Profile - Movement (range 4-20) higher = possible dysfunction	8.0 score on a scale Standard Deviation 2.0	7.9 score on a scale Standard Deviation 2.4
Discharge Questionnaire PSI- Defensive Responding (range 7-35) Higher = more dysfunction	13.3 score on a scale Standard Deviation 5.4	13.0 score on a scale Standard Deviation 6.1
Discharge Questionnaire PSI - Difficult Child (range 12-60) Higher = more dysfunction	18.2 score on a scale Standard Deviation 5.2	17.4 score on a scale Standard Deviation 5.7
Discharge Questionnaire Edinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression	9.0 score on a scale Standard Deviation 4.7	8.5 score on a scale Standard Deviation 5.5
Discharge Questionnaire STAI - Trait Anxiety (range 20-80) Higher = more anxiety	37.0 score on a scale Standard Deviation 11.5	34.8 score on a scale Standard Deviation 14.7
Discharge Questionnaire Sensory Profile - Touch (range 3-15) - higher = possible dysfunction	4.3 score on a scale Standard Deviation 1.8	4.8 score on a scale Standard Deviation 2.1
Discharge Questionnaire Sensory Profile - Auditory (range 4-20) higher = possible dysfunction	9.2 score on a scale Standard Deviation 3.7	8.1 score on a scale Standard Deviation 3.4
Discharge Questionnaire Sensory Profile - Visual (range 4-20)higher = possible dysfunction	6.7 score on a scale Standard Deviation 4.0	5.6 score on a scale Standard Deviation 2.8
Discharge Questionnaire Sensory Profile - Oral (range 2-10) higher = possible dysfunction	4.6 score on a scale Standard Deviation 1.9	4.2 score on a scale Standard Deviation 1.7
Discharge Questionnaire Sensory Profile - General (range 8-40) higher = possible dysfunction	14.1 score on a scale Standard Deviation 5.7	14.9 score on a scale Standard Deviation 5.6
Discharge Questionnaire PSI - Parental Distress (range 12-60) Higher = more dysfunction	22.7 score on a scale Standard Deviation 7.7	22.6 score on a scale Standard Deviation 10.0
Discharge Questionnaire PSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction	19.6 score on a scale Standard Deviation 5.4	18.7 score on a scale Standard Deviation 7.5
Discharge Questionnaire Parental Stressor Scale - NICU (range 0-5), Higher = more stress	3.1 score on a scale Standard Deviation 1.2	2.5 score on a scale Standard Deviation 1.0
Discharge Questionnaire STAI - State Anxiety (range 20-80) Higher = more anxiety	38.5 score on a scale Standard Deviation 11.9	35.1 score on a scale Standard Deviation 17.9
Discharge Questionnaire Maternal Confidence Questionnaire (range 0-56) Higher = more stress	44.2 score on a scale Standard Deviation 9.0	49.1 score on a scale Standard Deviation 7.6
Discharge Questionnaire ICQ - Mom and Baby (range 0-5), Higher = better care	4.3 score on a scale Standard Deviation 0.5	4.3 score on a scale Standard Deviation 0.8
Discharge Questionnaire ICQ - Emotionality (range 0-5), Higher = better care	4.2 score on a scale Standard Deviation 0.9	4.3 score on a scale Standard Deviation 0.9
Discharge Questionnaire ICQ - Responsiveness (range 0-5), Higher = better care	3.7 score on a scale Standard Deviation 0.8	4.1 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Control n=21 Participants The control group received standard hospital care.	Intervention n=18 Participants 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.
1 Year Follow-Up Questionnaire PSI - Parental Distress (range 12-60), Higher = more dysfunction	20.8 score on a scale Standard Deviation 7.8	20.6 score on a scale Standard Deviation 11.6
1 Year Follow-Up Questionnaire STAI - State Anxiety (range 20-80), Higher = more anxiety	33.7 score on a scale Standard Deviation 9.6	28.9 score on a scale Standard Deviation 9.0
1 Year Follow-Up Questionnaire ASQ - Personal-Social (range 0-60), higher = better	36.0 score on a scale Standard Deviation 17.8	40.3 score on a scale Standard Deviation 16.4
1 Year Follow-Up Questionnaire Sensory Profile - Touch (range 10-50), higher = more dysfunction	16.9 score on a scale Standard Deviation 6.2	19.7 score on a scale Standard Deviation 4.3
1 Year Follow-Up Questionnaire Sensory Profile - Movement Processing (range 6-30), Higher = more dysfunction	18.8 score on a scale Standard Deviation 3.8	20.3 score on a scale Standard Deviation 2.9
1 Year Follow-Up Questionnaire Sensory Profile - General (range 10-50), Higher = more dysfunction	14.2 score on a scale Standard Deviation 6.6	13.9 score on a scale Standard Deviation 6.1
1 Year Follow-Up Questionnaire PSI - Defensive Responding (range 7-35), Higher = more dysfunction	11.9 score on a scale Standard Deviation 4.4	11.7 score on a scale Standard Deviation 7.0
1 Year Follow-Up Questionnaire PSI - Difficult Child (range 12-60), higher = more dysfunction	20.1 score on a scale Standard Deviation 6.3	17.8 score on a scale Standard Deviation 8.1
1 Year Follow-Up Questionnaire Beck Depression Inventory (range 0-63), Higher = more depression	3.6 score on a scale Standard Deviation 4.1	3.9 score on a scale Standard Deviation 5.9
1 Year Follow-Up Questionnaire STAI - Trait Anxiety (range 20-80), Higher = more anxiety	35.8 score on a scale Standard Deviation 9.3	28.8 score on a scale Standard Deviation 13.1
1 Year Follow-Up Questionnaire Maternal Confidence Questionnaire (range 0-56), Higher = more confidence	51.4 score on a scale Standard Deviation 5.2	52.4 score on a scale Standard Deviation 3.2
1 Year Follow-Up Questionnaire ICQ - Mom and Baby (range 0-5), higher = better care	4.2 score on a scale Standard Deviation 0.9	4.3 score on a scale Standard Deviation 0.9
1 Year Follow-Up Questionnaire ICQ - Emotionality (range 0-5), higher = better care	4.1 score on a scale Standard Deviation 0.9	3.8 score on a scale Standard Deviation 1.7
1 Year Follow-Up Questionnaire ICQ - Responsiveness (range 0-5), higher = better care	4.5 score on a scale Standard Deviation 1.0	4.6 score on a scale Standard Deviation 1.1
1 Year Follow-Up Questionnaire ASQ - Communication (range 0-60), Higher = better	38.6 score on a scale Standard Deviation 18.1	48.6 score on a scale Standard Deviation 10.3
1 Year Follow-Up Questionnaire ASQ - Problem Solving (range 0-60), Higher = better	35.8 score on a scale Standard Deviation 20.4	41.1 score on a scale Standard Deviation 14.2
1 Year Follow-Up Questionnaire ASQ - Gross Motor (range 0-60), Higher = better	34.1 score on a scale Standard Deviation 22.6	42.8 score on a scale Standard Deviation 19.6
1 Year Follow-Up Questionnaire ASQ - Fine Motor (range 0-60), higher = better	46.5 score on a scale Standard Deviation 10.4	47.8 score on a scale Standard Deviation 14.0
1 Year Follow-Up Questionnaire Sensory Profile - Auditory (range 7-35), Higher = more dysfunction	9.7 score on a scale Standard Deviation 4.6	9.7 score on a scale Standard Deviation 5.0
1 Year Follow-Up Questionnaire Sensory Profile - Visual (range 8-40), Higher = more dysfunction	22.0 score on a scale Standard Deviation 4.3	21.6 score on a scale Standard Deviation 4.2
1 Year Follow-Up Questionnaire Sensory Profile - Oral (range 7-35), higher = more dysfunction	11.4 score on a scale Standard Deviation 4.7	10.6 score on a scale Standard Deviation 4.4
1 Year Follow-Up Questionnaire Sensory Profile - Behavior (range 6-30), Higher = more dysfunction	10.6 score on a scale Standard Deviation 5.3	11.2 score on a scale Standard Deviation 3.6
1 Year Follow-Up Questionnaire Pediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction	54.1 score on a scale Standard Deviation 31.6	61.2 score on a scale Standard Deviation 28.7
1 Year Follow-Up Questionnaire Behavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction	55.4 score on a scale Standard Deviation 16.2	51.0 score on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Control n=21 Participants The control group received standard hospital care.	Intervention n=18 Participants 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.
Mother-Infant Interaction (at 1 Year Follow-up)	17.8 score on a scale Standard Deviation 6.2	14.3 score on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Parent Engagement During Hospitalization Average number of days per 5-day week parents visited	3.9 Days Standard Deviation 1.3	3.9 Days Standard Deviation 1.2
Parent Engagement During Hospitalization Average number of days per 5-day week parents held infant	3.7 Days Standard Deviation 1.1	3.7 Days Standard Deviation 1.3
Parent Engagement During Hospitalization Average number of days per 5-day week parents provided skin-to-skin care	1.6 Days Standard Deviation 1.6	1.8 Days Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=17 Participants The control group received standard hospital care.	Intervention n=12 Participants 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.
Language Environmental Acquisition Device (LENA) Adult Word Count	4618.1 words Standard Deviation 3934.0	4338.5 words Standard Deviation 4818.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=28 Participants The control group received standard hospital care.	Intervention n=24 Participants 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.
Percentage of Sensory Interventions Received	80.5 percentage of interventions received Standard Deviation 51.4	122.7 percentage of interventions received Standard Deviation 34.9

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberta Pineda

Washington University

Phone: 314-286-1304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place