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

NCT07789145 | Not Yet Recruiting

• 1 other identifier: STU20252355
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

neonatal intensive care unit; NICU; postpartum depression; dyadic intervention; reading to infant; EPDS; infant; neonate; postpartum; mother; caregiver; Edinburgh Postnatal Depression Scale

Outcome Measures

Primary Outcomes (6)

• Change in Infant heart rate

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Caregiver Outcome

  Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

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

Interventions

Reading Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• the caregiver has cognitive impairments or under legal guardianship;
• the caregiver is unable to speak;
• the infant is under foster care at the time of enrollment.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal Program Manager

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08