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Trial record 1 of 2 for:    preterm | multisensory | Columbus, Ohio, U.S.
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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 : March 24, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Nathalie Maitre, Nationwide Children's Hospital

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. The current proposal 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.

Condition or disease Intervention/treatment Phase
Preterm Infant Device: Multisensory intervention Behavioral: Standard of care Device: Secondary Study: Contingent speech sound learning in infants Not Applicable

Detailed Description:

The proposed 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 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 of age and language and motor outcomes will be assessed at 2 years. Except for parent reports, all measures will be administered by masked examiners.

Secondary Study: Contingent speech sound learning in infants-We will conduct a randomized controlled trial (RCT) of standardized environmental practices vs. pacifier-activated player with female voice audio recording in either English (passive listening controls), French, or Chinese (active). The standard practice will include Sounds of Love program (standard approved clinical protocol: therapist voice audio recording in English played for the infant several times per day). The experimental conditions will include delivery of an audio recording in French or Chinese containing female voice readings and lullaby singing via a Pacifier Activated Lullaby system, an FDA approved sound player that provides the sound contingent on the infant sucking on their pacifier. Group 1 will be passive listening to the recording in English, Group 2 will be contingent listening to the audio recording in French, and Group 3 will be contingent listening to the recording in Chinese. With a sample size of 20 infants per group, we estimate a power of 86.9% with an alpha level of 0.05. Hypothesis: Infants exposed to a specific language will have better speech sound discrimination for that language, but not for the other two languages. In addition, exposure to foreign language contingently will not decrease discrimination of speech sounds in English as compared to the control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Intervention
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.

Device: Secondary Study: Contingent speech sound learning in infants
We will conduct a trial of two experimental conditions (n= 20 in each group). The sound recordings are provided up to 2 times per day 15 minutes each time, with 20 total sessions within a 2 to 3 week period. All recordings are of infant-directed female voice audio of lullabies and reading. Contingent listening is via a Pacifier Activated Lullaby system, an FDA approved sound player that provides the sound contingent of the infant sucking on their pacifier. The sessions for this condition will be provided up to 2 times per day, 15 minutes each time, with 20 total sessions within a 2 to 3-week period.

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


  2. 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.

  3. 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.


Other Outcome Measures:
  1. Secondary Study: Contingent speech sound learning in infants [ Time Frame: 6mo corrected Age or 3mo post intervention ]
    DAYC-2 Communication Domain

  2. Secondary Study: Contingent speech sound learning in infants [ Time Frame: Pre-intervention and 6mo corrected Age or 3mo post intervention ]
    ERP/EEG



Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalization at Nationwide Children's Hospital
  • Postmenstrual Age 32 0/7-35 6/7

Exclusion Criteria:

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

Secondary Study: Contingent speech sound learning in infants

Inclusion Criteria:

  • Hospitalization at NCH NICU OR enrollment in NCH Child Care Center
  • Postmenstrual age 36-64 weeks at the time of study start
  • Medically stable, as determined by the medical team
  • English as only language spoken by parents

Exclusion Criteria:

  • Significant ventilator support (includes CPAP)
  • Significant brain malformation or injury
  • Family history of genetic hearing loss
  • On sedatives/seizure medications
  • NAS treated pharmacologically
  • Significant oral aversion as determined by the medical team

Information from the National Library of Medicine

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


Contacts
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Contact: Stephanie Burkhardt, MPH (614) 722-4883 Stephanie.burkhardt@nationwidechildrens.org

Locations
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United States, Ohio
Stephanie Burkhardt Recruiting
Columbus, Ohio, United States, 43205
Contact: Stephanie Burkhardt, MPH    614-722-4883    stephanie.burkhardt@nationwidechildrens.org   
Contact: Stephanie Burkhardt         
Sponsors and Collaborators
Nationwide Children's Hospital
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Nathalie L Maitre, MD, PhD Nationwide Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nathalie Maitre, Associate Professor and Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03232931    
Other Study ID Numbers: IRB17-00025/IRB18-00579
R01HD093706 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nathalie Maitre, Nationwide Children's Hospital:
auditory
tactile
mother's voice
multisensory
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications