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NCT Number: NCT07789145

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

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.

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Key information

Conditions

Infant Admitted to Neonatal Intensive Care Unit (NICU) Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Reading Intervention

Behavioral

The intervention consists of the following content:

  • Handouts explaining the benefits of reading to your infant will be provided and discussed at the time of enrollment.
  • 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.
  • 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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