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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07789145
Enrollment
120
Registered
2026-08-27
Start date
2026-09-14
Completion date
2029-01-15
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Infant heart rateBaseline (at start of the intervention), 2 minutes into the interventionHeart 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.
Change in Infant Respiratory rateBaseline (at start of the intervention), 2 minutes into the interventionRespiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Change in Infant Oxygen saturation levelBaseline (at start of the intervention), 2 minutes into the interventionOxygen 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

MeasureTime frameDescription
Caregiver OutcomeSurvey 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026