Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05004857 |
Other study ID # |
2021-611 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 17, 2021 |
Est. completion date |
March 2024 |
Study information
Verified date |
March 2023 |
Source |
Tulane University |
Contact |
Meghan Howell, MD, MS |
Phone |
504-428-9201 |
Email |
mhowell2[@]tulane.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.