Supporting and Enhancing NICU Sensory Experiences (SENSE) (SENSE)
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ClinicalTrials.gov Identifier: NCT03316547 |
Recruitment Status :
Completed
First Posted : October 20, 2017
Results First Posted : July 7, 2021
Last Update Posted : July 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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Premature Birth of Newborn | Other: SENSE Program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | SENSE program-treatment; standard-of-care-control |
Masking: | Double (Care Provider, Outcomes Assessor) |
Masking Description: | Parents were asked to participate in a study investigating 2 different approaches to sensory exposures in the NICU. The approach (SENSE or standard of care) were described after enrollment, based on which group they were randomized to. The evaluator was blinded to treatment assignment. |
Primary Purpose: | Treatment |
Official Title: | Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants |
Actual Study Start Date : | August 16, 2017 |
Actual Primary Completion Date : | November 1, 2019 |
Actual Study Completion Date : | November 1, 2019 |
Arm | Intervention/treatment |
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No Intervention: Control
The control group received standard hospital care.
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Experimental: Intervention
Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable.
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Other: SENSE Program
Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
Other Name: Sensory-Based Intervention |
- Ages and Stages Questionnaire (ASQ) - Communication at 1 Year [ Time Frame: One year corrected age ]Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
- Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age [ Time Frame: At term equivalent age (35-41 weeks PMA) ]Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome.
- Language Environmental Acquisition Device (LENA) [ Time Frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. ]Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure.
- Sensory Exposures Provided During Hospitalization [ Time Frame: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months). ]During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete.
- Dubowitz/Hammersmith Neonatal Neurological Evaluation [ Time Frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. ]At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome.
- General Movement Assessment (GMA) [ Time Frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. ]A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis.
- Discharge Questionnaire [ Time Frame: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age). ]Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, & difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below.
- 1 Year Follow-Up Questionnaire [ Time Frame: One year corrected age. ]The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable.
- Mother-Infant Interaction (at 1 Year Follow-up) [ Time Frame: One year corrected age. ]At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction.
- Parent Engagement During Hospitalization [ Time Frame: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months). ]On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care.
- Language Environmental Acquisition Device (LENA) Adult Word Count [ Time Frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. ]Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording.
- Percentage of Sensory Interventions Received [ Time Frame: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age). ]Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented.
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Ages Eligible for Study: | up to 32 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316547
United States, Missouri | |
St. Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Roberta G Pineda, PhD, OTR/L | Washington University School of Medicine; University of Southern California |
Documents provided by Washington University School of Medicine:
Other Publications:
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03316547 |
Other Study ID Numbers: |
201601057 |
First Posted: | October 20, 2017 Key Record Dates |
Results First Posted: | July 7, 2021 |
Last Update Posted: | July 7, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
preterm |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |