Clinical trial NCT05004857: The Effect of Reading Therapy on Newborns
Official title: The Effect of Reading Therapy on Newborns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autonomic Nervous System Diseases
Keywords: Reading
Neonates
New borns
Autonomic nervous system
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Saul's Light Foundation
First posted: 2021-08-13
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this pilot study is to specifically examine the effect of parental reading on the ANS of mother and neonate in the hospital setting. The investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns.

Detailed description: Supporting infant ANS development has been implicated in their improved cardiorespiratory and neuropsychiatric outcome; furthermore, improved parasympathetic activity, a branch of ANS, is a predictor of the mother-infant relationship, and the best marker for caregiving behavior. In Feldman and Eidelman's 2003 study, they demonstrated that mother-infant skin-to-skin contact, also known as Kangaroo Care, accelerates ANS maturation in pre-term infants, which is critical for their recovery. If reading is shown to have a positive effect on mother infant ANS, hospitals will be able to incorporate this into practice as a feasible alternative for when Kangaroo Care isn't possible. The investigators hope to learn if these reading interventions will help to mitigate distress symptoms, among both mother and baby, within the hospital. The investigators will examine the association of reading therapy with the infant's crying patterns, length of stay in the hospital, weight gain, and behavior compared to before the reading was done.

Seeing that Scala's findings from 2018 is the only indication of physiologic benefits of reading to infants in the hospital, additional research is required in this particular area. The testing and application of reading therapy in the Neonatal Intensive Care Unit (NICU) would improve a high-stress environment for both parents and infants. Data collected from this project will not only add some much-needed information to the limited knowledge of the physiological effects of reading on neonates, but also demonstrate how infant outcomes can be improved in a cost-effective, efficient manner within the hospital setting.

Eligibility criteria: Inclusion Criteria:

* Admitted to the Tulane-Lakeside Hospital Newborn Nursery
* Corrected gestational age 34 weeks or older
* No identified hearing disorder
* Do not have a diagnosed developmental disability (i.e. Down Syndrome)
* Do not have Fetal Alcohol Syndrome
* Medically cleared to participate in the study
* Biological mother able/willing to give consent in English \& complete surveys.

Exclusion Criteria:

* Corrected gestational age \< 34 weeks old
* Has an identified or potential hearing disorder (i.e, failed hearing screen)
* Has diagnosed developmental disability (i.e. Down syndrome)
* Has Fetal Alcohol Syndrome
* Is not medically cleared to participate in the study
* Biological mother unable/unwilling to give consent.

Primary outcomes:
measure: Determine the change in vagal tone
timeFrame: 20 minutes of reading
measure: Determine the change in parasympathetic nervous system response
timeFrame: 20 minutes of reading
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Meghan Howell, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: