The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit

August 24, 2026 updated by: Carissa Gasparovic, University of Texas Southwestern Medical Center

The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and following discharge. The specific aims are:

Aim 1: To evaluate the primary outcome of infant physiological response, including heart rate, respiratory rate, and oxygen saturation, when read by their caregiver. Infant heart rate, respiratory rate and oxygen saturations (SpO2) will be measured 15 minutes prior to the intervention, at start of the intervention, 2 minutes into the intervention, and 15 minutes after the intervention is completed. Outcomes will be compared to those of a control group.

Aim 2: To explore the secondary outcome of the intervention effect on maternal mental health, as measured by changes in postpartum depression (PPD) scores.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. the infant must have a NICU LOS > 3 days;
  2. a dedicated caregiver, such as parent, relative, friend of the family, grandparent are present in NICU;
  3. the primary caregiver can read and speak in English.

Exclusion Criteria:

  1. Infants with a confirmed diagnosis of hearing loss will be excluded from the study, as the intervention is based on auditory stimulation through shared reading;
  2. the caregiver has cognitive impairments or under legal guardianship;
  3. the caregiver is unable to speak;
  4. the infant is under foster care at the time of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Intervention Group
Receive additional information on the benefits of reading to your infant. They will be instructed to participate in a minimum of 3 structured reading sessions and how to log each session.
Behavioral: Reading Intervention

The intervention consists of the following content:

  1. Handouts explaining the benefits of reading to your infant will be provided and discussed at the time of enrollment.
  2. Instructions outlining that a minimum of 3 reading sessions, lasting at least 2 minutes, should be provided to the infant, and how to log the reading sessions.
  3. Information on how to obtain books from the NICU library if choosing to utilize that resource. Parents will be informed that they can bring in their own books from home should they want to.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Infant heart rate
Time Frame: Baseline (at start of the intervention), 2 minutes into the intervention
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant heart rate
Time Frame: Baseline (at start of the intervention),15 minutes after the intervention
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Baseline (at start of the intervention),15 minutes after the intervention
Change in Infant Respiratory rate
Time Frame: Baseline (at start of the intervention), 2 minutes into the intervention
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant Respiratory rate
Time Frame: Baseline (at start of the intervention), 15 minutes after the intervention
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Baseline (at start of the intervention), 15 minutes after the intervention
Change in Infant Oxygen saturation level
Time Frame: Baseline (at start of the intervention), 2 minutes into the intervention
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant Oxygen saturation level
Time Frame: Baseline (at start of the intervention), 15 minutes after the intervention
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
Baseline (at start of the intervention), 15 minutes after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Outcome
Time Frame: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 14, 2026

Primary Completion (Estimated)

September 14, 2028

Study Completion (Estimated)

January 15, 2029

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20252355

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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