Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/8/2019 |
| Start Date: | October 29, 2018 |
| End Date: | October 31, 2022 |
| Contact: | Ashley Miller, MT-BC |
| Email: | Ashley.miller2@nationwidechildrens.org |
| Phone: | (614) 722-4815 |
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. 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.
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.
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.
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.
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
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-4815
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