An interventional study of SENSE Program in Premature Birth of Newborn, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged Up to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
Preterm Infants:
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:
Parents:
-Parents with limited or no understanding of the English Language
The control group received standard hospital care.
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.
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.
Also known as: Sensory-Based Intervention
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
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)
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.
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).
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.
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.
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).
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.
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.
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).
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.
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).
| Milestone | Control | Intervention |
|---|---|---|
| Started | 39 | 31 |
| Completed | 21 | 18 |
| Not completed | 18 | 13 |
| Withdrew: Death | 3 | 1 |
| Withdrew: Lost to follow-up | 6 | 6 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Transfer to another hospital | 6 | 4 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Ages and Stages Questionnaire (ASQ) - Communication at 1 Year | 38.6 ± 18.1 | 48.6 ± 10.3 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age | 4.4 ± 2.7 | 4.1 ± 2.2 |
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.
| percentage of 16h recording | Control | Intervention |
|---|---|---|
| % Meaningful words | 2.4 ± 1.5 | 3.9 ± 3.0 |
| % Distant words | 2.6 ± 2.6 | 3.7 ± 2.6 |
| % TV or electronic sounds | 14.8 ± 14.0 | 14.3 ± 17.4 |
| % Noise | 12.5 ± 9.7 | 10.2 ± 9.1 |
| % Silence | 67.7 ± 17.8 | 68.0 ± 18.5 |
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.
| Participants | Control | Intervention |
|---|---|---|
| # of infants who received > 75% of recommended doses of sensory interventions | 14 | 24 |
| # of infants who received 100% of recommended doses of sensory interventions | 8 | 15 |
| Parent provided > 50% of interventions received | 12 | 12 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Dubowitz/Hammersmith Neonatal Neurological Evaluation | 22.8 ± 4.0 | 20.6 ± 3.4 |
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.
No measurements were reported for this outcome.
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Sensory Profile - Touch (range 3-15) - higher = possible dysfunction | 4.3 ± 1.8 | 4.8 ± 2.1 |
| Sensory Profile - Auditory (range 4-20) higher = possible dysfunction | 9.2 ± 3.7 | 8.1 ± 3.4 |
| Sensory Profile - Visual (range 4-20)higher = possible dysfunction | 6.7 ± 4.0 | 5.6 ± 2.8 |
| Sensory Profile - Movement (range 4-20) higher = possible dysfunction | 8.0 ± 2.0 | 7.9 ± 2.4 |
| Sensory Profile - Oral (range 2-10) higher = possible dysfunction | 4.6 ± 1.9 | 4.2 ± 1.7 |
| Sensory Profile - General (range 8-40) higher = possible dysfunction | 14.1 ± 5.7 | 14.9 ± 5.6 |
| PSI- Defensive Responding (range 7-35) Higher = more dysfunction | 13.3 ± 5.4 | 13.0 ± 6.1 |
| PSI - Parental Distress (range 12-60) Higher = more dysfunction | 22.7 ± 7.7 | 22.6 ± 10.0 |
| PSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction | 19.6 ± 5.4 | 18.7 ± 7.5 |
| PSI - Difficult Child (range 12-60) Higher = more dysfunction | 18.2 ± 5.2 | 17.4 ± 5.7 |
| Edinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression | 9.0 ± 4.7 | 8.5 ± 5.5 |
| Parental Stressor Scale - NICU (range 0-5), Higher = more stress | 3.1 ± 1.2 | 2.5 ± 1.0 |
| STAI - State Anxiety (range 20-80) Higher = more anxiety | 38.5 ± 11.9 | 35.1 ± 17.9 |
| STAI - Trait Anxiety (range 20-80) Higher = more anxiety | 37.0 ± 11.5 | 34.8 ± 14.7 |
| Maternal Confidence Questionnaire (range 0-56) Higher = more stress | 44.2 ± 9.0 | 49.1 ± 7.6 |
| ICQ - Mom and Baby (range 0-5), Higher = better care | 4.3 ± 0.5 | 4.3 ± 0.8 |
| ICQ - Emotionality (range 0-5), Higher = better care | 4.2 ± 0.9 | 4.3 ± 0.9 |
| ICQ - Responsiveness (range 0-5), Higher = better care | 3.7 ± 0.8 | 4.1 ± 0.9 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| PSI - Defensive Responding (range 7-35), Higher = more dysfunction | 11.9 ± 4.4 | 11.7 ± 7.0 |
| PSI - Parental Distress (range 12-60), Higher = more dysfunction | 20.8 ± 7.8 | 20.6 ± 11.6 |
| PSI - Difficult Child (range 12-60), higher = more dysfunction | 20.1 ± 6.3 | 17.8 ± 8.1 |
| Beck Depression Inventory (range 0-63), Higher = more depression | 3.6 ± 4.1 | 3.9 ± 5.9 |
| STAI - State Anxiety (range 20-80), Higher = more anxiety | 33.7 ± 9.6 | 28.9 ± 9.0 |
| STAI - Trait Anxiety (range 20-80), Higher = more anxiety | 35.8 ± 9.3 | 28.8 ± 13.1 |
| Maternal Confidence Questionnaire (range 0-56), Higher = more confidence | 51.4 ± 5.2 | 52.4 ± 3.2 |
| ICQ - Mom and Baby (range 0-5), higher = better care | 4.2 ± 0.9 | 4.3 ± 0.9 |
| ICQ - Emotionality (range 0-5), higher = better care | 4.1 ± 0.9 | 3.8 ± 1.7 |
| ICQ - Responsiveness (range 0-5), higher = better care | 4.5 ± 1.0 | 4.6 ± 1.1 |
| ASQ - Communication (range 0-60), Higher = better | 38.6 ± 18.1 | 48.6 ± 10.3 |
| ASQ - Problem Solving (range 0-60), Higher = better | 35.8 ± 20.4 | 41.1 ± 14.2 |
| ASQ - Gross Motor (range 0-60), Higher = better | 34.1 ± 22.6 | 42.8 ± 19.6 |
| ASQ - Fine Motor (range 0-60), higher = better | 46.5 ± 10.4 | 47.8 ± 14.0 |
| ASQ - Personal-Social (range 0-60), higher = better | 36.0 ± 17.8 | 40.3 ± 16.4 |
| Sensory Profile - Touch (range 10-50), higher = more dysfunction | 16.9 ± 6.2 | 19.7 ± 4.3 |
| Sensory Profile - Auditory (range 7-35), Higher = more dysfunction | 9.7 ± 4.6 | 9.7 ± 5.0 |
| Sensory Profile - Visual (range 8-40), Higher = more dysfunction | 22.0 ± 4.3 | 21.6 ± 4.2 |
| Sensory Profile - Movement Processing (range 6-30), Higher = more dysfunction | 18.8 ± 3.8 | 20.3 ± 2.9 |
| Sensory Profile - Oral (range 7-35), higher = more dysfunction | 11.4 ± 4.7 | 10.6 ± 4.4 |
| Sensory Profile - General (range 10-50), Higher = more dysfunction | 14.2 ± 6.6 | 13.9 ± 6.1 |
| Sensory Profile - Behavior (range 6-30), Higher = more dysfunction | 10.6 ± 5.3 | 11.2 ± 3.6 |
| Pediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction | 54.1 ± 31.6 | 61.2 ± 28.7 |
| Behavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction | 55.4 ± 16.2 | 51.0 ± 16.1 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Mother-Infant Interaction (at 1 Year Follow-up) | 17.8 ± 6.2 | 14.3 ± 6.0 |
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.
| Days | Control | Intervention |
|---|---|---|
| Average number of days per 5-day week parents visited | 3.9 ± 1.3 | 3.9 ± 1.2 |
| Average number of days per 5-day week parents held infant | 3.7 ± 1.1 | 3.7 ± 1.3 |
| Average number of days per 5-day week parents provided skin-to-skin care | 1.6 ± 1.6 | 1.8 ± 1.7 |
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.
| words | Control | Intervention |
|---|---|---|
| Language Environmental Acquisition Device (LENA) Adult Word Count | 4618.1 ± 3934.0 | 4338.5 ± 4818.8 |
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.
| percentage of interventions received | Control | Intervention |
|---|---|---|
| Percentage of Sensory Interventions Received | 80.5 ± 51.4 | 122.7 ± 34.9 |
Collected over 1 year, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 3/39 (7.7%) | 0/39 (0%) | 0/39 (0%) |
| Intervention | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Control | Intervention | Total |
|---|---|---|---|
| <=18 years | 39 | 31 | 70 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(EGA at birth (weeks)) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 29.5 ± 2.5 | 29.7 ± 2.6 | 29.6 ± 2.5 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 28 | 19 | 47 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 13 | 23 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 29 | 18 | 47 |
| Region of Enrollment(Participants) | Control | Intervention | Total |
|---|---|---|---|
| United States | 39 | 31 | 70 |
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