Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants

Not Applicable

Active, not recruiting

• Conditions: Preterm Infant
• Interventions: Behavioral: Therapist skin-to-skin Care; Behavioral: Parental skin-to-skin care; Device: Contingent parent's voice exposure; Device: Recorded parent's voice

• Registration Number: NCT03232931
• Lead Sponsor: Emory University

Brief Summary

Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth. This study uses rigorous scientific methods to measure the effects and determine the mechanisms of action of a parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable to a wide variety of neonatal environments, even when parents cannot be at their child's bedside. The intervention aims to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.

Detailed Description

This study is 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 unit care (i.e., 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 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. Event-related potential (ERP) testing will be performed prior to the prior to intervention and after intervention is complete, which occurs at 36 weeks postmenstrual age (PMA) on average. ERP testing will take approximately 30 to 40 minutes. All infants will be seen at the neonatal intensive care unit (NICU) Follow-Up Program clinics at 9-12 months PMA (Year 1) and 22-24 months PMA (Year 2), where neurodevelopmental outcomes will be assessed using standardized methods.

Parents will also have the opportunity to consent separately to a secondary part to the study in which their infant would participate in one additional ERP testing session in the NICU between 34-36 weeks PMA and one additional visit to the clinical laboratory for ERP testing between 3-4 months PMA. This optional, secondary part of the study is observational only and does not influence randomization for the main trial. For the secondary part of the study, the population will be 40 of the 230 participants. All parents who are approached for the study prospectively and are randomized to control group will be asked if they would like to participate in the secondary part. Enrollment for this secondary part of the study will stop when 40 participants are reached.

Study Timeline

• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2018-10-29
• Primary Completion: 2023-02-20
• Status Verified: 2024-02
• Results First Submitted: 2024-02-19
• Results First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Results First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• Hospitalization at a study location
• Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation

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Exclusion Criteria

• Ventilation using an endotracheal tube
• Major congenital malformations
• Family history of genetic hearing loss
• Use of sedatives or seizure medications

Secondary Study Inclusion Criteria:

• Enrolled in the control group of the main study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multisensory Intervention	Therapist skin-to-skin Care	Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 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. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Standard of Care	Parental skin-to-skin care	Preterm infants in the NICU who are randomized to receive the standard of care. The standard care for preterm infants in the NICU currently follows medical protocols of skin-to-skin holding and exposure to recordings of parent's voice.
Multisensory Intervention	Parental skin-to-skin care	Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 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. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Multisensory Intervention	Contingent parent's voice exposure	Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 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. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Multisensory Intervention	Recorded parent's voice	Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 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. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.
Standard of Care	Recorded parent's voice	Preterm infants in the NICU who are randomized to receive the standard of care. The standard care for preterm infants in the NICU currently follows medical protocols of skin-to-skin holding and exposure to recordings of parent's voice.

Primary Outcome Measures

Name	Time	Method
Index of Multisensory Processing (IMP)	At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation	Cortical processing is measured as the percentage of time spent in Event Related Potential (ERP) response patterns that have been previously characterized as typical in healthy infants born at full term. ERP is assessed through high-density functional electroencephalogram (EEG) in the NICU. The Index of Multisensory Processing (IMP) is calculated as the percentage of time that the topographical pattern of the participant's ERP to multisensory stimuli is most like template map of a full term infant. The IMP is expressed as a percentage from 100% (samples show nearly-typical activation all of the time) to 0% (samples show nearly-typical activation none of the time).

Secondary Outcome Measures

Name	Time	Method
Infant/Toddler Sensory Profile (ITSP) Score	at 12 months corrected age	The Infant/Toddler Sensory Profile (ITSP), for ages 7 to 36 months, is a 48-item questionnaire, completed by caregivers, and is used to measure sensory reactivity and adaptation to the environment. The ITSP assesses five sensory processing sections (Auditory, Visual, Tactile, Vestibular, and Oral Sensory Processing) and a General measure. Responses are given on a 5-point scale where 1 = almost always and 5 = almost never. For children 7 to 36 months there are 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 performance is 46-54) Sensation Seeking: 14-70 (typical performance is 19-35) Sensory Sensitivity: 11-55 (typical performance is 41-52) Sensation Avoiding: 12-60 (typical performance is 45-56) Low Threshold (combined quadrant score): 23-115 (typical performance is 87-107)
Change in Preschool Language Scales - 5th Edition (PLS-5) Score	2 Years (22-26 months corrected age)	The PLS-5 is a language assessment tool administered by a trained professional in which children point or verbally respond to pictures or objects. It assesses both receptive (auditory comprehension) and expressive language skills in young children, and a total language score is also calculated. Total scores for Auditory Comprehension, Expressive Communication, and Total Language are standardized with a mean of 100 and a standard deviation of 15. Scores below 100 indicate below average performance while scores above 100 indicate better than average performance.
Change in Bayley Scales of Infant and Toddler Development - 3rd Edition (Bayley III) Score	12 and 24 months corrected age	The Bayley-III is a 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.

Trial Locations

Locations (3)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States