About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Reading Intervention
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Caregiver Outcome
Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
Locations
Sponsors and contacts
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