NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University of Texas Southwestern Medical Center
Conditions: Infant Admitted to Neonatal Intensive Care Unit (NICU)
Interventions: Reading Intervention
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.
Sex: ALL
Healthy volunteers: No
Study type: INTERVENTIONAL
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.