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Behavioral Intervention

Reading Therapy for Newborn Care

N/A

Waitlist Available

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

Must not have

Is not medically cleared to participate in the study

Corrected gestational age < 34 weeks old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes of reading

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My baby is at least 34 weeks in corrected gestational age.

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I do not have a hearing disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not medically approved to join the study.

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My baby was born before 34 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minutes of reading

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the change in parasympathetic nervous system response

Determine the change in vagal tone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Book reading

2022

N/A

~150

0 / 4Eligibility criteria met