Preterm InfantNCT03232931
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
A study testing Therapist skin-to-skin Care, Contingent parent's voice exposure and Parental skin-to-skin care in people with Preterm Infant, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 36 weeks
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Therapist skin-to-skin Care, Contingent parent's voice exposure and Parental skin-to-skin care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Oct 2018to 25 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalization at a study location
- Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Randomized Controlled Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
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.
Read the 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.
- Conditions
- Preterm Infant
- Being tested
- Therapist skin-to-skin Care, Contingent parent's voice exposure, Parental skin-to-skin care, Recorded parent's voice
- Keywords
- auditory, tactile, mother's voice, multisensory
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist skin-to-skin CareBehavioural
Skin-to-skin (STS) holding is part of the multisensory intervention where the therapist will wear a clean 100% cotton T-shirt with a clean hospital gown on top of the shirt and wrap the "kangaroo" positioner securely over the gown. A gauze square scented with parent's skin will be used to provide olfactory stimulation. Therapist STS sessions occur with simultaneous playing of mother's voice contingent on infant pacifier sucking.
Contingent parent's voice exposureDevice
Also called Pacifier Activated Lullaby® (PAL®)
The parent's voice recording is delivered via a pacifier-activated music player (PAM). The Pacifier Activated Lullaby® (PAL®) device, is a digital music delivery system that integrates a sensor, a pacifier routinely used in the NICU, and a receiver. It delivers a predetermined 10 seconds of recorded parent's voice singing lullabies upon detection of a suck that meets a preset pressure threshold. The original systems were modified for research use by decreasing the lower limit of activation thresholds for delivering the recording. Minimal effort is required to trigger the device. However, the settings ensure that regular attempts are needed to continue to receive continual presentation of the recording of mother's voice by requiring another suck after 10 seconds. The auditory stimulation with PAL will be provided when the infants are still awake (i.e., at the beginning of the session).
Parental skin-to-skin careBehavioural
The standard of care includes parental skin-to-skin care and exposure to parent's voice. During parental skin-to-skin care, infants are placed in a prone position with head positioned over the sternum, allowing transmission of breath and heart sounds to the developing ear. Deeper pressure is applied to offer support and feedback to the child's bottom. Session length is set to a minimum of 45 minutes per unit protocols.
Recorded parent's voiceDevice
Also called DINO-egg
Per standard of care, preterm infants in the NICU currently receive noncontingent recorded parents' voice during two 20 minute sessions per day. Recordings are standardized and are played through a sterilizable device (DINO-egg).
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Intervention | Experimental | 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. Receives: Behavioral: Therapist skin-to-skin Care; Device: Contingent parent's voice exposure; Behavioral: Parental skin-to-skin care; Device: Recorded parent's voice |
| Standard of Care | Other | 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. Receives: Behavioral: Parental skin-to-skin care; Device: Recorded parent's voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of Multisensory Processing (IMP)
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).
Measured: At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation
Secondary outcomes (3)
Infant/Toddler Sensory Profile (ITSP) Score
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)
Measured: at 12 months corrected age
Change in Bayley Scales of Infant and Toddler Development - 3rd Edition (Bayley III) Score
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.
Measured: 12 and 24 months corrected age
Change in Preschool Language Scales - 5th Edition (PLS-5) Score
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.
Measured: 2 Years (22-26 months corrected age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start29 Oct 2018
- Primary completion20 Feb 2023
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nationwide Children's Hospital
- Responsible party
- Principal investigator, Nathalie Maitre, Emory University
- Investigators
- Nathalie L Maitre, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232931
- Sponsor's protocol ID
- STUDY00003034
- Other IDs
- R01HD093706, IRB17-00025/IRB18-00579, 2024P007108
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2017
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maitre NL, Kjeldsen CP, Jeanvoine A, Lukemire J, Slaughter JL, Key AP. The MIND Randomized Controlled Trial: An Intervention to Improve Neural Speech Processing and 2-Year Language Outcomes of Infants Born Preterm. J Pediatr. 2026 Jun 5;296:115187. doi: 10.1016/j.jpeds.2026.115187. Online ahead of print.
PubMed 42250747Richard C, Jeanvoine A, Stark AR, Hague K, Kjeldsen C, Maitre NL. Randomized Trial to Increase Speech Sound Differentiation in Infants Born Preterm. J Pediatr. 2022 Feb;241:103-108.e3. doi: 10.1016/j.jpeds.2021.10.035. Epub 2021 Oct 25.
PubMed 34710395Neel ML, Yoder P, Matusz PJ, Murray MM, Miller A, Burkhardt S, Emery L, Hague K, Pennington C, Purnell J, Lightfoot M, Maitre NL. Randomized controlled trial protocol to improve multisensory neural processing, language and motor outcomes in preterm infants. BMC Pediatr. 2019 Mar 19;19(1):81. doi: 10.1186/s12887-019-1455-1.
PubMed 30890132