Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT03232931|
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infant||Device: Multisensory intervention Behavioral: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized controlled trial design with intent-to-treat analysis in hospitalized preterm infants between 32 and 36 weeks post-menstrual age. Both the control and intervention groups will receive routine neonatal intensive care protocols (including skin-to-skin care by parent when available and daily sessions of exposure to recorded parent's voice). In addition to routine care, the parent-supported multisensory intervention consists of 10 sessions of standardized, therapist-administered, auditory-tactile stimulation that combines contingent recorded mother's voice delivered using a pacifier-activated system, during holding with supportive tactile containment against the therapist's chest, covered by cloth imprinted with mother's scent. Possible covariates, multi- and uni- sensory processing, will be measured at entry into the study and immediately after the treatment phase. Sensory reactivity will be measured at 1 year and language and motor outcomes will be assessed at 2 years.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Except for parent reports, all measures will be administered by masked examiners.|
|Official Title:||Randomized Controlled Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||May 30, 2023|
The Multisensory intervention will be carried out in addition to standard care and will include 2 components: (1) holding and light pressure containment of the infant against the hospital-gown covered chest of the therapist for tactile and non-specific auditory stimulation simultaneous with (2) playing of mother's voice contingent on infant pacifier sucking for the first 20 minutes of holding. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Device: Multisensory intervention
The intervention will be carried out in addition to standard care and will include 2 components: (1) holding and light pressure containment of the infant against the hospital-gown covered chest of the therapist for tactile and non-specific auditory stimulation simultaneous with (2) playing of mother's voice contingent on infant pacifier sucking for the first 20 minutes of holding. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Control (standard of care)
The standard care of infant currently follows 2 medical protocols, one for parental Skin-to-Skin holding and one for exposure to parent's voice.
Behavioral: Standard of care
Standard of care: parental skin-to-skin care and exposure to parent's voice
- Latency of response to auditory and tactile stimuli on EEG/ERP [ Time Frame: at enrollment up to 36 weeks gestation and at intervention completion up to 42 weeks gestation ]Change from baseline event related potential multisensory response at term-equivalent age (up to 42 weeks gestation)
- Infant/Toddler Sensory Profile (ITSP) [ Time Frame: at 12 months corrected age ]
Infant/Toddler Sensory Profile: A caregiver questionnaire used to measure sensory reactivity and adaptation to the environment of children birth to 36 months. The Infant/Toddler Sensory Profile consists of 48 items for children 7 to 36 months. The caregiver questionnaire contains items divided into sensory systems. For children 7 to 36 months, there are five sensory processing section scores, four quadrant scores, and one combined quadrant score available. For children 12 months corrected age, the four quadrant score ranges are as follows:
Low Registration: 11-55 ("typical" is 46-54) Sensation Seeking: 14-70 ("typical" is 19-35) Sensory Sensitivity: 11-55 ("typical" is 41-52) Sensation Avoiding: 12-60 ("typical" is 45-56)
- Motor and language scores on Bayley-III [ Time Frame: 12 and 24 months corrected age ]Bayley Scales of Infant and Toddler Development (Bayley-III): Standardized comprehensive assessment tool for assessing child development in children one month to 42 months old. The highest possible scaled score on each subtest is 19, and the lowest possible score is 1. Scores from 8 to 12 are considered average. Composite scores for motor and language domains are derived from sums of the subtest scaled scores. Composite scores range from 40-160.
- Preschool Language Scales, Fifth Edition (PLS-5) [ Time Frame: 24 months corrected age ]Preschool Language Scales, Fifth Edition (PLS-5): An interactive assessment of developmental language skills in children birth-7. A standard score of 100 reflects the average performance of children in a given age range.
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): NCT03232931
|Contact: Stephanie Burkhardt, MPH||(614) 722-4883||Stephanie.firstname.lastname@example.org|
|United States, Ohio|
|Columbus, Ohio, United States, 43205|
|Contact: Stephanie Burkhart, MPH 301-712-8852 email@example.com|
|Contact: Stephanie Burkhart 13017128852|
|Principal Investigator:||Nathalie L Maitre, MD, PhD||Nationwide Children's Hospital|