An interventional study of Parent-Facilitated Early Oral-Sensory Experience (PEOE) in Premature Birth, Infant, Premature and Infant, Very Premature, sponsored by Boston College. Not yet recruiting. Open to participants aged 0 Days to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Boston College · Not applicable, Interventional, and Supportive care
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
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Very preterm infants born at less than 32 weeks gestational age
Exclusion Criteria:
Parent-infant dyads receiving standard NICU care and standard enteral feeding without structured oral-sensory stimulation.
Parent-infant dyads receiving up to five individualized coaching sessions with a trained interventionist. Parents deliver the Parent-Facilitated Early Oral-Sensory Experience (PEOE) intervention independently during NICU visits up to four times daily before and/or during gavage feedings until oral feeding initiation.
Behavioral: Parent-Facilitated Early Oral-Sensory Experience (PEOE)
Parents administer small droplets of human milk (expressed breast milk or donor milk, up to 1 mL) orally via syringe, guided by infant readiness cues (e.g., mouthing, rooting). This is paired with synchronized multisensory stimulation (gentle touch, parental voice, parental scent, and taste/smell of milk). Sessions start immediately before gavage feedings and may continue into the feeding. Sessions occur in the incubator or during skin-to-skin care up to four times daily.
Study Feasibility and Acceptability Rates
Composite measure of study feasibility evaluated by overall eligibility rate, recruitment rate, enrollment rate, retention rate, and intervention protocol completion rate.
Time frame: From screening through NICU discharge (up to 6 weeks after enrollment).
Infant Short-Term Heart Rate Response Across Intervention Sessions
Change in mean heart rate in beats per minute (bpm) and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention.
Time frame: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Respiratory Rate Response Across Intervention Sessions
Change in mean respiratory rate (breaths per minute) and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention.
Time frame: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Oxygen Saturation Response Across Intervention Sessions
Change in mean oxygen saturation (SpO2) percentage and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention.
Time frame: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Heart Rate Variability (High-Frequency HRV) Across PEOE Intervention Sessions
Change in high-frequency heart rate variability (HF-HRV in ms2) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention.
Time frame: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Heart Rate Variability (SD12 Ratio) Across Intervention Sessions
Change in Poincare nonlinear ratio (SD12) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention.
Time frame: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Heart Rate Response During Feeding Near Discharge
Change in mean heart rate (bpm) and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Respiratory Rate Response During Feeding Near Discharge
Change in mean respiratory rate (breaths per minute) and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Oxygen Saturation Response During Feeding Near Discharge
Change in mean oxygen saturation (SpO2) percentage and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Heart Rate Variability (High-Frequency HRV) During Feeding Near Discharge
Change in high-frequency heart rate variability (HF-HRV in ms2) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Heart Rate Variability (SD12 Ratio) During Feeding Near Discharge
Change in Poincare nonlinear ratio (SD12) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Splanchnic-to-Cerebral Oxygenation Ratio Pre- to Post-Feeding Near Discharge
Change in splanchnic-to-cerebral oxygen ratio (SOCR) measured via near-infrared spectroscopy (NIRS) from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Behavioral Feeding Regulation Near Discharge
Infant overall behavioral feeding skill evaluated during a single discharge feeding observation using the Early Feeding Skills (EFS) assessment tool total score (score range 19-57, higher scores indicate greater feeding skill and regulation).
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Parental Depressive Symptoms Score
Parental depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS) total score (range 0-30, higher scores indicate greater depressive symptoms).
Time frame: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parental Anxiety State Score
Parental anxiety symptoms assessed using the State-Trait Anxiety Inventory-Short Form (STAI-SF) total score (range 20-80, higher scores indicate higher anxiety).
Time frame: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parental NICU Stress Score
Parental stress resulting from the NICU environment assessed using the Parental Stressor Scale: NICU (PSS:NICU) total metric score (range 1-5, higher scores indicate greater stress).
Time frame: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parenting Self-Efficacy
Task-specific parenting confidence score evaluated using the Karitane Parenting Confidence Scale (KPCS; score range 0 to 45, with higher scores indicating greater confidence).
Time frame: At enrollment and at discharge (up to 6 weeks post-enrollment)
Parent Feeding Co-Regulation Skill Score
Parent responsive feeding co-regulation capability assessed via videotaped discharge feeding observations using the Dynamic-Early Feeding Skills (D-EFS) Caregiver Feeding Action subscale. Calculated as the percentage of total feeding duration that the parent spends engaged in responsive co-regulation behaviors (range 0% to 100% of feeding time, where a higher percentage indicates greater parent co-regulatory skill and responsiveness).
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Length of NICU Hospital Stay
Total length of hospital stay measured in cumulative days from infant birth through final NICU discharge (extracted from electronic health records).
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Time to Achieve Full Oral Feeding
Number of days required from study enrollment for the infant to achieve full oral feeding, defined as consuming 100% of daily enteral nutrition by mouth for at least 48 consecutive hours (extracted from electronic health records).
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Infant Weight Gain Velocity
Average infant weight gain velocity calculated in grams per kilogram per day (g/kg/day) from baseline enrollment to NICU discharge (extracted from electronic health records).
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 18 months is below that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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