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

NCT07789145 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-27

No results posted yet for this study

Summary

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.

Conditions

  • Infant Admitted to Neonatal Intensive Care Unit (NICU)

Interventions

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.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-14
Primary Completion
2028-09-14
Completion
2029-01-15

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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 NCT07789145 on ClinicalTrials.gov