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The Effect of Reading Therapy on Newborns

NCT05004857 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Autonomic Nervous System Diseases

Interventions

BEHAVIORAL

Book reading

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.

Sponsors & Collaborators

  • Saul's Light Foundation

    collaborator UNKNOWN

  • Tulane University

    lead OTHER

Principal Investigators

  • Meghan Howell, MD, MS · Tulane University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Max Age
1 Week
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004857 on ClinicalTrials.gov