An interventional study of Reading Intervention in Infant Admitted to Neonatal Intensive Care Unit (NICU), sponsored by University of Texas Southwestern Medical Center. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Other
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 120 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at start of the intervention), 15 minutes after the intervention
Caregiver Outcome
Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
Time frame: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center →