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NCT07883707
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Conditions: Premature Birth, Infant, Premature, Infant, Very Premature
Sex: All
Ages: 0 Days – 32 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Boston College
Summary
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit (NICU). Very preterm infants (born before 32 weeks gestational age) often face challenges developing oral feeding skills. The PEOE intervention involves training parents to deliver gentle, synchronized oral-sensory stimulation-such as placing small droplets of human milk in the infant's mouth paired with gentle touch, voice, and scent-starting immediately before gavage feedings and potentially continuing into the feeding. This study uses a sequential two-group design. The first group of parents and infants will receive usual NICU care. The second group will receive the PEOE intervention. Researchers will measure how feasible and acceptable the program is for parents and staff, infant physiological responses, feeding skill development, length of hospital stay, and parental emotional well-being.
Eligibility Criteria
Inclusion Criteria:
Very preterm infants born at less than 32 weeks gestational age
* Admitted to the Beth Israel Deaconess Medical Center (BIDMC) Neonatal Intensive Care Unit (NICU)
* Commenced or scheduled to commence enteral feedings
* Parent or legal guardian of an eligible infant
* Parent age 18 years or older
* Parent literate in English, Spanish, or Portuguese
* Parent available to participate in study data collection and/or intervention sessions
Exclusion Criteria:
* Born at 32 weeks gestational age or greater
* Presence of major congenital malformations of the mouth, face, or gastrointestinal tract
* Serious comorbidities that interfere with normal oral feeding development
Source: ClinicalTrials.gov (NCT07883707). StuddyBuddy aggregates publicly available trial information.