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Behavioral Intervention

Reading Therapy for Newborn Care

N/A
Recruiting
Led By Meghan Howell, MD, MS
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Corrected gestational age 34 weeks or older
No identified hearing disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes of reading
Awards & highlights

Study Summary

This trial is testing whether reading to newborns has physiological benefits.

Who is the study for?
This trial is for typically developing newborns, aged 34 weeks or older, admitted to Tulane-Lakeside Hospital Newborn Nursery. Their biological mothers must be able to consent in English and complete surveys. Babies with developmental disabilities, hearing disorders, Fetal Alcohol Syndrome, or not medically cleared are excluded.Check my eligibility
What is being tested?
The study investigates the impact of live maternal-infant book reading on the autonomic nervous system (ANS) of both mother and child in a hospital setting. It aims to understand how this activity might benefit typically developing infants physiologically.See study design
What are the potential side effects?
Since the intervention involves reading books to newborns by their mothers, there are no expected pharmacological side effects. However, it's important to monitor for any signs of distress or overstimulation in the infant during the sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is at least 34 weeks in corrected gestational age.
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I do not have a hearing disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes of reading
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes of reading for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the change in parasympathetic nervous system response
Determine the change in vagal tone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient armExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,482 Total Patients Enrolled
Saul's Light FoundationUNKNOWN
Meghan Howell, MD, MSPrincipal InvestigatorTulane University

Media Library

Book reading (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05004857 — N/A
Autonomic Nervous System Disorders Research Study Groups: Patient arm
Autonomic Nervous System Disorders Clinical Trial 2023: Book reading Highlights & Side Effects. Trial Name: NCT05004857 — N/A
Book reading (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004857 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll in this clinical trial?

"Qualifications for this medical trial necessitate that participants suffer from segmental autonomic dysfunction and be between 1 Minute to 1 Week old. Altogether, 20 patients are being accepted into the program."

Answered by AI

What is the maximum enrollment for this clinical trial?

"Yes, the available clinicaltrial.gov data reveals that this medical trial is actively sourcing 20 individuals from a single site. The initial post date for the study was September 17th 2021 and it has been updated most recently on April 5th 2022."

Answered by AI

Is the research team still enlisting participants for this clinical trial?

"Indeed, according to the information publicly available on clinicaltrials.gov this trial is open for recruitment. It was first proclaimed on September 17th 2021 and recently updated on April 5th 2022; with a total of 20 participants needed at one site."

Answered by AI

Does the study accept participants aged 35 or older?

"According to the prerequisites listed in this study, the minimum age of participation is 1 Minute and no one over 1 Week old may enroll."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of Reading Therapy on Newborns
2021. "The Effect of Reading Therapy on Newborns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004857.
~6 spots leftby Apr 2025
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