Reading Therapy for Newborn Care

Recruiting at 1 trial location

Overseen By Asha Dash, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 minutes per session

Trial Summary

What is the purpose of this trial?

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.

Research Team

Meghan Howell, MD, MS

Principal Investigator

Tulane University

Eligibility Criteria

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.

Inclusion Criteria

Do not have Fetal Alcohol Syndrome

Do not have a diagnosed developmental disability (i.e. Down Syndrome)

Medically cleared to participate in the study

Exclusion Criteria

Has an identified or potential hearing disorder (i.e, failed hearing screen)

Has diagnosed developmental disability (i.e. Down syndrome)

Has Fetal Alcohol Syndrome

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive reading therapy to examine its effect on the ANS of mother and neonate

20 minutes per session

Daily sessions in the hospital

Follow-up

Participants are monitored for changes in parasympathetic nervous system response and vagal tone

1-2 weeks

Treatment Details

Interventions

• Book reading

Trial Overview 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.

Participant Groups

Group I: Patient arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Saul's Light Foundation

Collaborator

Trials

1

Recruited

1+