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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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