The Effect of Reading Therapy on Newborns

NCT05004857 | Active Not Recruiting

• 1 other identifier: 2021-611
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Reading; Neonates; New borns; Autonomic nervous system

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  20 minutes of reading

Study Arms (1)

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.

Behavioral: Book reading

Interventions

Book reading BEHAVIORAL

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.

Patient arm

Eligibility Criteria

• Age: 1 Minute - 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead
• Saul's Light Foundation: collaborator

Study Sites (1)

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Meghan Howell, MD, MS

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: September 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)