The Effect of Reading Therapy on Newborns
Primary Purpose
Autonomic Nervous System Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Book reading
Sponsored by
About this trial
This is an interventional supportive care trial for Autonomic Nervous System Diseases focused on measuring Reading, Neonates, New borns, Autonomic nervous system
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.
Sites / Locations
- Tulane University Health Sciences CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient arm
Arm Description
The subject population will be newborn infants admitted to the Newborn Nursery (NN) at Tulane Lakeside Hospital. The investigators are anticipating some mothers can be recruited from the prenatal clinics who expect to deliver at Tulane Hospital during pregnancy as well.
Outcomes
Primary Outcome Measures
Determine the change in vagal tone
The change in vagal tone from the reading therapy will be measured using MindWare System, where an increase in vagal tone shows positive physiological outcomes in the newborns and mothers.
Determine the change in parasympathetic nervous system response
The change in parasympathetic nervous system response from the reading therapy will be measured using MindWare System, where an increase in parasympathetic nervous system response shows positive physiological outcomes in the newborns and mothers.
Secondary Outcome Measures
Full Information
NCT ID
NCT05004857
First Posted
August 6, 2021
Last Updated
March 21, 2023
Sponsor
Tulane University
Collaborators
Saul's Light Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05004857
Brief Title
The Effect of Reading Therapy on Newborns
Official Title
The Effect of Reading Therapy on Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University
Collaborators
Saul's Light Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases
Keywords
Reading, Neonates, New borns, Autonomic nervous system
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient arm
Arm Type
Experimental
Arm Description
The subject population will be newborn infants admitted to the Newborn Nursery (NN) at Tulane Lakeside Hospital. The investigators are anticipating some mothers can be recruited from the prenatal clinics who expect to deliver at Tulane Hospital during pregnancy as well.
Intervention Type
Behavioral
Intervention Name(s)
Book reading
Intervention Description
Prior to the first session, a research assistant will place electrodes on the infant and mother so that they study team can gather autonomic nervous system (ANS) response (sympathetic and parasympathetic) non-invasively using MindWare Portable Lab System (MindWare Technologies, Gahanna, Ohio). These electrodes will remain on the infant and mother throughout each session and be removed via adhesive removing pads following each session's data collection. This will minimize discomfort to both parties secondary to electrode removal and minimize risk of skin irritation by leaving electrodes in place for a prolonged period of time. Additional observational data before and after the reading sessions will be collected by the research assistant, including but not limited to: where the session is conducted (mother's arms, bassinet), activity level, vital signs, and any other observed behaviors throughout the session.
Primary Outcome Measure Information:
Title
Determine the change in vagal tone
Description
The change in vagal tone from the reading therapy will be measured using MindWare System, where an increase in vagal tone shows positive physiological outcomes in the newborns and mothers.
Time Frame
20 minutes of reading
Title
Determine the change in parasympathetic nervous system response
Description
The change in parasympathetic nervous system response from the reading therapy will be measured using MindWare System, where an increase in parasympathetic nervous system response shows positive physiological outcomes in the newborns and mothers.
Time Frame
20 minutes of reading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Howell, MD, MS
Phone
504-428-9201
Email
mhowell2@tulane.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Asha Dash, BS
Phone
504-228-9433
Email
adash1@tulane.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan Howell, MD, MS
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Howell, MD, MS
Phone
504-428-9201
Email
mhowell2@tulane.edu
First Name & Middle Initial & Last Name & Degree
Asha Dash, BS
Phone
504-228-9433
Email
adash1@tulane.edu
First Name & Middle Initial & Last Name & Degree
Meghan Howell, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Reading Therapy on Newborns
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