Autonomic Nervous System DiseasesNCT05004857
The Effect of Reading Therapy on Newborns
A study testing Book reading in people with Autonomic Nervous System Diseases, run by Tulane University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Diseases
- What is being tested?
- Book reading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 minute to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
About this study
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.
Read the 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.
- Conditions
- Autonomic Nervous System Diseases
- Being tested
- Book reading
- Keywords
- Reading, Neonates, New borns, Autonomic nervous system
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Book readingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient arm | Experimental | 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. Receives: Behavioral: Book reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes of reading
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.
Measured: 20 minutes of reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start17 Sep 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseasesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Saul's Light Foundation
- Responsible party
- Sponsor
- Investigators
- Meghan Howell, MD, MS, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004857
- Sponsor's protocol ID
- 2021-611
- Status last verified
- May 2026
- First submitted
- 6 Aug 2021
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reading Therapy on Newborns
- ClinicalTrials.gov ID
- NCT05004857
- Acronym / sponsor ID
- 2021-611
- Conditions
- Autonomic Nervous System Diseases
- Keywords
- Reading, Neonates, New borns, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Saul's Light Foundation
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient arm | Experimental | Behavioral: Book readingThe 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. |
Who may qualify
- Ages
- 1 minute to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Book readingPrior 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. | Behavioural | Patient arm |
Primary outcome
Determine the change in vagal tone
Time frame: 20 minutes of reading
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
Time frame: 20 minutes of reading
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Autonomic Nervous System Diseases
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
Active, not recruitingPhase 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Howell, MD, MS principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Book reading in people with Autonomic Nervous System Diseases, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the change in vagal tone (time frame: 20 minutes of reading). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.